[Federal Register Volume 74, Number 158 (Tuesday, August 18, 2009)]
[Notices]
[Pages 41713-41734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-19680]


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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, 301-827-1463.
    Office of the Chief Scientist: The organizational change will allow 
the agency to better focus the science and research activities under 
the Chief Scientist. Re-alignments under the Office of the Chief 
Scientist will include the Office of Counter-Terrorism and Emerging 
Threats, Office of Critical Path Programs, Office of Scientific 
Integrity, and the Office of Science and Innovation.
    Office of Administration: The Office of Operations will be re-
titled the Office of Administration. The Office of Administration will 
be restructured to strengthen agency wide management programs, budget 
and shared services operations, as well as the Office of the 
Commissioner's executive operations. Realignments of the Office of 
Acquisitions and Grants Services, the Office of Executive Operations, 
the Office of Information Management, the Office of Management, the 
Office of Equal Employment Opportunity and Diversity Management, and 
the establishment of the Office of Financial Operations.
    Office of Foods: The Office of Foods will be realigned from the 
Office of Operations and will report directly to the Commissioner.
    Office of Policy, Planning and Budget: The Office of Policy, 
Planning and Preparedness will be retitled the Office of Policy, 
Planning and Budget. The realignments from the Office of Policy, Office 
of Planning, and the Office of Budget Formulation (formerly titled the 
Office of Budget Formulation and Presentation, Office of Operations).
    [Part D, Chapter D-B, (Food and Drug Administration), the Statement 
of Organization, Functions, and Delegations of Authority for the 
Department of Health and Human Services (35 FR 3685, February 25, 1970, 
and 60 FR 56605, November 9, 1995, 64 FR 36361, July 6, 1999, 72 FR 
50112, August 30, 2007) is amended to reflect the restructuring of the 
Office of the Commissioner (OC), Food and Drug Administration (FDA) as 
follows].
    I. Under Part D, Food and Drug Administration, delete the Office of 
Commissioner in its entirety and replace with the following:
    DA.10 ORGANIZATION. The Food and Drug Administration (FDA) is 
headed by the Commissioner, Food and Drug, and includes the following 
organizational units:
    Office of the Commissioner
    Office of the Chief Counsel
    Office of the Chief of Staff
    Office of Legislation
    Office of Policy, Planning and Budget
    Office of Counselor to the Commissioner
    Office of Women's Health
    Office of Special Medical Programs
    Office of External Affairs
    Office of Foods
    Office of the Chief Scientist
    Office of International Programs
    Office of Administration
    Office of Equal Employment Opportunity and Diversity Management
    Center for Tobacco Products
    DA.20 FUNCTIONS.
    Office of the Commissioner: The Office of the Commissioner (OC) 
includes the Commissioner and Deputy Commissioner who are responsible 
for the efficient and effective implementation of the FDA mission.
    Office of the Chief Counsel: The Office of the Chief Counsel (OCC) 
is also known as the Food and Drug Division, Office of the General 
Counsel, Department of Health and Human Services. While 
administratively within the Office of the Commissioner, the Chief 
Counsel is part of the Office of the General Counsel of the Department 
of Health and Human Services.
    1. Is subject to the professional supervision and control of the 
General Counsel, Department of Health and Human Services (DHHS), and 
represents FDA in court proceedings and administrative hearings with 
respect to programs administered by FDA.
    2. Provides legal advice and policy guidance for programs 
administered by FDA.
    3. Acts as liaison to the Department of Justice and other Federal 
agencies for programs administered by FDA.
    4. Drafts or reviews all proposed and final regulations and Federal 
Register notices prepared by FDA.
    5. Performs legal research and gives legal opinions on regulatory 
issues, actions, and petitions submitted to FDA.

[[Page 41714]]

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

[[Page 41715]]

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

[[Page 41716]]

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

[[Page 41717]]

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

[[Page 41718]]

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

[[Page 41719]]

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

[[Page 41720]]

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

[[Page 41721]]

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

[[Page 41722]]

    1. Provides strategic leadership, coordination, infrastructure and 
support for excellence and innovation in FDA science that will advance 
the agency's ability to protect and promote the health of the public. 
Key activities include:
    Providing support for high quality, collaborative, peer-reviewed 
scientific activities throughout FDA that address important public 
health and regulatory issues concerning FDA regulated products, 
including their evaluation, quality, safety and effectiveness.
    Fostering development and use of innovative technologies to meet 
public health needs, including through a planned Center for Innovation 
in Medicine and Public Health and through core scientific capacity to 
support FDA's regulatory functions and decision making.
    Supporting excellence and the professional development of FDA 
scientists in all areas (i.e. population/statistical, review, 
laboratory and manufacturing sciences), including through the 
Commissioner's Fellowship Program, continuing education and 
professional activities (including clinical activities, cross agency 
working groups, and through relationships and staff exchanges with 
Universities and others.
    Addressing scientific and public health priorities through support 
of high quality, peer reviewed scientific research, programs and 
related activities, both within and outside FDA and collaboratively, 
and through dissemination of new scientific information, methods and 
approaches.
    Supporting scientific outreach, training, and collaboration in 
research and development activities that advance FDA's mission, 
including with sister agencies, global regulatory partners, academia 
(e.g., through planned Centers of Excellence in Regulatory Science), 
innovators, and consumers.
    Seeking input from both FDA programs, stakeholders and outside 
advisors, including the FDA Science Board, to help define, review and 
meet FDA scientific needs and priorities to support our public health 
mission.
    Office of International Programs:
    1. Serves as the agency focal point for all international matters.
    2. Serves as the primary agency liaison with other U.S. Government 
components, international and foreign governments (including 
Washington, DC embassies) for policy formulation and execution 
impacting FDA and FDA regulated products.
    3. Provides leadership to agency program areas for international 
activities.
    4. Serves as the focal point for the agency and the authority for 
policies and procedures pertaining to international travel.
    5. Serves as the focal point and final clearing authority for all 
international technical cooperation and assistance activities.
    6. Serves as the agency focal point and final clearing authority 
for all international programs and interactions with foreign 
counterpart regulatory agencies, international organizations, foreign 
embassies, all foreign officials, and with agency and all other United 
States Government components when international issues are involved.
    7. Directs, manages, and leads agency strategic planning, priority-
setting and resource allocation processes for agency international 
programs.
    8. Serves as the agency focal point and final clearing authority 
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

[[Page 41723]]

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

[[Page 41724]]

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.

[[Page 41725]]

    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

[[Page 41726]]

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:

[[Page 41727]]

    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

[[Page 41728]]

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

[[Page 41729]]

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,

[[Page 41730]]

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

[[Page 41731]]

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, 
the Smithsonian Institution, and other government, academic, and 
private institutions.
    5. Collects, processes, and preserves artifacts that capture the 
history of FDA's work, represent the commodities it regulates, and 
document the breadth of its responsibilities. Mounts a variety of 
exhibits in collaboration with other public and private institutions to 
educate agency employees and the public about the history and work of 
the FDA.
    6. Partners with the National Library of Medicine, History of 
Medicine Division, to create and make available transcripts and 
recordings of an oral history program that documents FDA's 
institutional history, through personal interviews with key exiting FDA 
employees.
    Office of Real Property Services:
    1. Provides leadership and guidance to agency components for all 
aspects of real property management functions.
    2. Directs the management of programs and systems leading to the 
acquisition, alteration, maintenance, and utilization of leased and 
owned facilities nationwide, except for the acquisition of buildings 
for the White Oak Headquarters Consolidation.
    3. Directs building operations functions for all Food and Drug 
Administration (FDA) facilities nationwide.
    4. Manages the program and provides direct interface with General 
Services Administration (GSA) for lease acquisition and lease 
management for all agency facilities nationwide.
    5. Serves as liaison with the Department of Health and Human 
Services (DHHS) and GSA for general facilities management issues and 
specifically for the efficient management and operation of facilities 
occupied by FDA programs nationwide.
    6. Directs and manages an excess of $221 million dollar 
appropriation for the acquisition, operation, construction, maintenance 
for the agency's nationwide real property portfolio.
    7. Provides leadership and direction to assure the efficient and 
effective utilization of FDA's resources dedicated to engineering 
design, facility improvements, and new construction of FDA facilities 
nationwide.
    8. Establishes management structure and dialog with GSA and the 
architectural engineering design and construction contractors to ensure 
FDA program needs and concerns are fully addressed.
    9. Ensures meaningful and continuous communication with community 
leaders and associations, State and local governments, and business 
leaders in areas where FDA proposes new facilities.
    10. Develops and implements program plans, policies and procedures 
designed to create and maintain a safe and healthful environment for 
FDA employees, visitors, and guest workers, and to protect the 
environment.
    11. Develops agency plans, policy and procedures consistent with 
new environmental health and safety regulatory requirements and agency 
needs. Provides fire protection, safety engineering, and environmental 
health consultation to the agency's program managers and engineering 
offices.
    12. Leads the agency's decommissioning efforts to close FDA 
laboratories and offices from an environmental, safety and health 
perspective.
    13. Consults with program officials on safety matters pertaining to 
changing and emerging research programs.
    14. Recommends special technical studies to increase the knowledge 
of the relationship between occupational safety and environmental 
health and laboratory programs of FDA.
    15. Provides support to the FDA Safety Advisory Board and conducts 
the FDA Safety and Health Council meetings.
    16. Develops and implements a safety management quality assurance 
program for the agency's multiple work sites nationwide. Develops and 
implements a similar headquarters program consistent with the FDA 
Safety Advisory Board recommendations and approval.
    Jefferson Laboratories Complex Staff:
    1. Provides leadership and direction regarding all aspects of 
facilities management.
    2. Manages and coordinates all aspects of the Jefferson 
Laboratories long range facilities planning.
    3. Develops renovation and improvement project definitions and 
priorities for inclusion in the agency's Annual Facilities Plan and 
budget.

[[Page 41732]]

    4. Provides leadership and direction to assure the efficient and 
effective utilization of Jefferson Laboratories resources dedicated to 
engineering design, facility improvements, maintenance and new 
construction projects.
    Division of Engineering Services:
    1. Manages and directs design and construction requirements for 
facility acquisitions within the agency. These requirements may 
encompass the following activities singularly or in combination; 
preparation of proposals, preparation of functional requirements, 
program of requirements and criteria, architect and engineering 
liaison, space design and planning, functional and technical reviews, 
preliminary site selections, and project management for facilities 
construction, renovation and improvement projects.
    2. Provides engineering guidance and support for all activities 
related to maintenance, alterations, and repairs for agency facilities 
nationwide.
    3. Directs and coordinates all agency facilities programs concerned 
with equipment specifications and installation associated with facility 
acquisitions. Assists the programs' staffs in developing compatible 
facilities and equipment systems for the agency.
    4. Provides overall engineering services including: feasibility 
studies, design criteria, concept, analysis, and estimates. Schedules 
and tracks building and facilities projects and manages project design.
    5. Manages the FDA energy management program; develops agency 
policy relating to the program; develops and enforces supporting agency 
standards that comply with stated goals of the Department.
    6. Oversight of structural, architectural or mechanical 
modifications to accommodate specific requirements in the existing FDA 
portfolio.
    7. Prepares computer--aided design (CAD) drawings for the agency 
and maintains file of master drawings for FDA portfolio.
    8. Administers agency contract for renovations/alterations of 
office space.
    9. Provides space and alterations project management for existing 
FDA space to program components.
    10. Develops, implements and manages integration of facilities 
technologies.
    Environment, Safety and Strategic Initiatives Staff:
    1. Manages the agency's Environment, Safety and Health (EH&S) 
Program;
    2. Oversees strategic management initiatives and programs initiated 
at Government-wide, Departmental, agency and Office levels.
    3. Oversees and directs a variety of commercial contracts or 
interagency agreements to ensure smooth and efficient delivery of 
services.
    4. Participates in the development of agency policy involving EH&S 
programs and services.
    5. Provides guidance and assistance to the agency operating 
activities on a variety of EH&S and Strategic management issues.
    6. Actively participates in and supports the agency Facility 
Management System used to manage FDA's Real Property Asset inventory.
    7. Receives and implements new initiatives for Real Property 
Services (e.g. President Management Agenda initiatives; Office of 
Management and Budget Scorecards; Department Objectives and agency 
initiatives)
    Division of Facilities Operations:
    1. Coordinates building operations and facilities management 
functions for all Food and Drug Administration (FDA) owned facilities 
within the Washington metropolitan area which includes: Module 1 (MOD 
1), and the Beltsville Research Facility (BRF). Through special 
delegations of authority from the General Services Administration 
(GSA), maintains responsibility for the total management, operation, 
and maintenance of Federal Building 8 (FB-8) and Module 2 (MOD 2).
    2. Oversees and directs a variety of commercial contracts to ensure 
smooth and efficient delivery of services.
    3. Participates in the development of agency policy involving 
building management and operations.
    4. Provides guidance and assistance to the agency operating 
activities on a variety of facilities operations issues.
    5. Coordinates office and laboratory relocations and provides 
technical assistance to programs regarding effective space utilization.
    6. Provides guidance to program personnel in identifying or 
developing alternatives or emergency procedures during scheduled and 
unscheduled maintenance interruptions.
    7. Administers agency contracts for moving services and preventive 
maintenance for government owned property.
    8. Manages and coordinates the General Services Administration 
Delegations of Authority program for FDA nationwide. Responds, reviews, 
and analyzes existing and proposed Delegation Agreements, Interagency 
Agreements, Memorandum of Understandings regarding the agency's 
nationwide property holdings for operational planning processes and 
improvement.
    Portfolio Development Staff:
    1. Plans and develops the agency Annual Facilities Plan that 
includes forecasts for long term, short term and immediate space needs 
as well as annual facilities budgets for rent, operations and 
maintenance and building and facilities.
    2. Develops multiple strategies for addressing FDA's long and short 
range facility plans.
    3. Develops agency standards and enforcement of occupied and vacant 
space utilization. 4. 4. 4. Prepares reports and space management 
analysis of the agency's real property holdings. 5. 5. Analyzes agency 
housing plans and performs real property occupied and vacant space 5. 
customer analysis.
    6. Provides cost analysis support to agency components concerned 
with leasing, construction, and finance costs.
    7. Manages the policy, acquisition, management and administration 
of the agency's leased real property portfolio.
    8. Provides guidance and assistance to the agency operating 
activities on a variety of nationwide real estate management issues.
    9. Serves as liaison with the Department of Health and Human 
Services (DHHS) and the General Services Administration (GSA) for all 
lease acquisition and lease management of FDA nationwide facilities.
    10. Conducts agency facility studies and develops specific long-
range facility plans for both headquarters and field operations.
    11. Directs or participates in, the preparation of the Program of 
Requirements for new construction projects.
    Center for Tobacco Products:
    1. The Center for Tobacco Products will be established to address 
the enactment of the Family Smoking and Tobacco Control Act. This 
Office will consist of an Office of Management, an Office of Policy, an 
Office of Regulations and an Office of Science.
    Office of the Center Director:
    1. Provides leadership and direction for all Center activities and 
coordinates programs within the agency, Department and government 
agencies.
    2. Plans, administers, coordinates, evaluates and implements 
overall Center scientific, regulatory, compliance, enforcement and 
management programs, policies and plans.
    3. Provides leadership and direction for Center management, 
planning, and evaluation systems to ensure optimum utilization of 
personnel, financial resources, and facilities.

[[Page 41733]]

    4. Establishes and manages a program to maintain the highest level 
of quality and integrity for all Center laboratory studies and the 
processing of regulatory samples, and ensures that all laboratories are 
in compliance with Good Laboratory Practice Regulations.
    5. Coordinates and monitors the Center's overall research 
portfolio, including all research-related activities and inquiries and 
the development of strategic research program plans.
    6. Serves as the primary representational role for relationships 
with the department, OMB, the White House, the Congress and the media.
    Office of Management:
    1. Provides support to the Center Director and Deputy Directors, 
including the coordination and preparation of briefing materials and 
background information for meetings, responses to outside inquires, and 
maintenance and control of the Center Director's working files.
    2. Manages the Center's Freedom of Information Act activities, 
coordinating responses with other Center technical, regulatory, and 
policy units as well as developing direct responses.
    3. Provides correspondence control for the Center and controls and 
processes all agency public correspondence directed to the Center 
Director. Develops and operates tracking systems designed to identify 
and resolve early warnings and bottleneck problems with executive 
correspondence.
    4. Coordinates the Center's communications with the agency, 
Department, and the other Federal government agencies.
    5. Provides authoritative advice and guidance to the Center 
Director on management policies, guidelines, issues and concerns that 
directly impact Center programs and initiatives.
    6. Provides leadership, guidance and directs the development of 
long-range strategic and operational plans and systems for Center 
activities and directs technical support staff in providing essential 
management services and other critical support functions.
    7. Provides leadership and guidance as primary interface working 
with the FDA Office of Shared Services to ensure provision of a broad 
range of essential technical support services.
    8. Provides leadership and effective coordination as the primary 
Center liaison and expert with the Office of Information Management for 
provision and continuous improvement of information and technology 
services for the Center to include networking, scientific computing 
software engineering, systems, and telecommunications.
    9. Administers and executes Center program planning and performance 
activities, budget formulation and execution, payroll, accounting, 
fleet and property management functions.
    10. Analyzes, formulates and develops annual budget for the Center 
in accordance with FDA, DHHS, OMB and Congressional guidelines. 
Provides oversight and ensures compliance with all regulations 
governing financial processes as outlined in OMB, GAO, DHHS and FDA 
policies.
    11. Manages and maintains a management system for center wide 
research and support functions.
    12. Develops, maintains, monitors, analyzes and reports data to 
Center management and program officials on the Center's budget/planning 
resource monitoring and evaluations systems.
    13. Manages, conducts, and analyzes studies designed to improve 
Center processes and resource utilization and support requirements.
    14. Provides leadership, guidance, technical support and assistance 
to Center managers, employees and shared services staff on services 
including timekeeping, payroll, fleet management, personal property 
management, travel, acquisitions and financial services.
    15. Provides leadership within the Center to assure compliance with 
statutes, executive orders and administrative directives, such as the 
Chief Financial Officer Act (CFO) and the Federal Financial Manager's 
Financial Integrity Act (FMFIA).
    Office of Policy:
    1. Advises the Center Director and other key agency officials on 
matters relating to agency policy, regulations and guidance, 
legislative issues, and planning and evaluation activities.
    2. Participates with the Center Director in the formulation of the 
basic policies and operational philosophy, which guide the agency in 
effectively implementing its responsibilities.
    3. Oversees and directs the Centers planning and evaluation 
activities, including the development of programs and planning 
strategies through analysis and evaluation of issues affecting policies 
and program performance.
    4. Advises and assists the Center Director and other key agency 
officials concerning legislative needs, pending legislation and 
oversight activities that affect FDA.
    5. Serves as the focal point for overall legislative liaison 
activities within Center, FDA and between FDA, the Department, PHS and 
other agencies related to Tobacco; analyzes the legislative needs of 
the Center and drafts or develops legislative proposals, position 
papers, and departmental reports on proposed legislation for approval 
by the Center Director and Commissioner.
    6. Advises and assists members of Congress and congressional 
committees and staffs in consultation with the Office of the Secretary, 
on agency actions, policies, and issues related to legislation which 
may affect the Center.
    Office of Regulations:
    1. Provides Center oversight and leadership in the development of 
regulations, policies, procedures and guidance for the review and 
regulation of tobacco products, their labels, and marketing, and in the 
development of new legislation.
    2. Provides Center oversight and leadership in the administration 
of the user fee billing and waiver program, and registration and 
listing.
    3. Coordinates, interprets, and evaluates the Center's overall 
compliance efforts. As necessary, establishes compliance policy or 
recommends policy to the Center Director.
    4. Oversees and directs the agency's rulemaking activities and 
regulation and guidance development system.
    5. Serves as the agency focal point for developing and maintaining 
communications, policies, and programs with regard to regulations 
development.
    6. Stimulates awareness within the agency of the need for prompt 
and positive action to assure compliance by regulated industries; works 
to assure an effective and uniform balance between voluntary and 
regulatory compliance and agency responsiveness to consumer needs.
    7. Evaluates and coordinates all proposed legal actions to 
ascertain compliance with regulatory policy and enforcement objectives.
    8. Develops and/or recommends to the Center Director policy, 
programs, and plans for activities between the agency and State and 
local agencies; administers the Center's overall Federal-State program 
and policy; coordinates the program aspects of agency contracts with 
State and local counterpart agencies.
    Office of Science:
    1. Serves as principal authority and provides leadership for the 
Center's participation in the National Toxicology Program (NTP).
    2. Organizes, plans, and directs Center research programs in 
accordance with Center-wide strategic direction. Implements Center-wide 
strategies for achieving annual and long-range plans for research.
    3. Provides leadership and direction for communications among 
scientific and administrative staffs.

[[Page 41734]]

    4. Organizes, plans, and directs the Center for research support in 
the areas of Tobacco.
    Directs the development methods used to extrapolate test results 
from animals to humans.
    5. Coordinates research in Center program areas with leading 
scientists in other segments of FDA and the scientific community at 
large and promotes and coordinates the Center's technology transfer 
under the provisions of the Federal Technology Transfer Act.
    6. Coordinates with other Center and agency components and top 
level officials of other agencies to provide input for long-term 
research planning in responsible program areas.
    7. Insures that programs implemented are responsive to the Center's 
portion of the agency's integrated research plan.
    8. Provides scientific oversight of Center research contracts and 
agreements.
    9. Advises and assists the Center Director, Deputy Director, and 
other key officials on scientific issues that have an impact on policy, 
direction, and long-range goals.
    10. Coordinates and provides guidance on special and overall 
science policy in program areas that cross major agency component lines 
and scientific aspects that are critical or controversial, including 
agency risk assessment policies.
    11. Represents the Center with other government agencies, state and 
local governments, industry, academia, consumer organizations, 
Congress, national and international organizations, and the scientific 
community on tobacco science policy and tobacco science issues.
    12. Serves as the focal point for overall management of Center 
activities related to science priorities, resources, and leveraging 
efforts, as well as peer review of scientists and scientific programs.
    13. Advises the Commissioner, Deputy Commissioner, and other key 
officials on scientific facilities and participates with other agency 
components in planning such facilities.
    14. Administers the Tobacco Advisory Committee that advises the 
Center Director, Deputy Director, and other key officials regarding the 
quality and direction of tobacco science and scientific issues.
II. Delegation of Authority. Pending further delegation, directives or 
orders by the Commissioner of the Food and Drugs, all delegations and 
redelegations of authority made to officials and employees of affected 
organizational components will continue in them or their successors 
pending further redelegations, provided they are consistent with this 
reorganization.

    Dated: August 7, 2009.
Kathleen Sebelius,
Secretary of Health and Human Services.
[FR Doc. E9-19680 Filed 8-17-09; 8:45 am]
BILLING CODE 4160-01-S