Office of the Commissioner Reorganization; Statement of Organizations, Functions, and Delegations of Authority, 7490-7512 [2010-3161]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 75, Number 33 (Friday, February 19, 2010)]
[Notices]
[Pages 7490-7512]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3161]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0376]


Office of the Commissioner Reorganization; Statement of 
Organizations, Functions, and Delegations of Authority

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

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

FOR FURTHER INFORMATION CONTACT: Vanessa Starks, Office of Management 
Programs (HFA-400), Food and Drug Administration, 5600 Fishers Lane, 
rm. 6B-42, Rockville, MD 20857, 301-827-1463.

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

[[Page 7491]]

to the Commissioner for integrating the efforts of all food-related 
programs in FDA, and for making optimal use of all available resources 
and methods to improve the safety, nutritional quality, and labeling of 
the food supply. The Office of Foods will provide executive leadership 
and management to the Center for Food Safety and Applied Nutrition and 
the Center for Veterinary Medicine (CVM). This Office will report 
directly to the Commissioner.
    Office of the Chief Scientist: The Office of the Chief Scientist 
will be restructured to facilitate the agency's focus on scientific 
innovation, recruiting a new generation of scientists, better utilizing 
our toxicological research center and improving our computing support 
for our scientific programs. This office will be led by the Chief 
Scientist. The offices within the Office of the Chief Scientist are as 
follows: The Office of Counter-Terrorism and Emerging Threats, Office 
of Critical Path Programs, the newly established Offices of Scientific 
Integrity and Science and Innovation. Additionally, the National Center 
for Toxicological Research has a direct reporting relationship to OC 
and an indirect reporting relationship to the Chief Scientist.
    Office of Administration: The Office of Operations will be retitled 
the Office of Administration. The Office of Administration will focus 
on enhancing agency-wide administrative operations and overseeing a 
variety of agency-wide management programs, information management, 
financial and shared services operations, as well as OC's executive 
operations. The new substructure of the Office of Administration 
consists of the Office of Acquisitions and Grants Services, the Office 
of Executive Operations, establishment of the Office of Financial 
Operations, the Office of Information Management and the Office of 
Management. The Office of Equal Employment Opportunity and Diversity 
Management will report directly to the Commissioner with a day-to-day 
operational relationship to the Deputy Commissioner for Administration.
    Center for Tobacco Products: The Center for Tobacco Products will 
be established to address the enactment of the Family Smoking 
Prevention and Tobacco Control Act. This Office will consist of the 
Office of the Center Director, Office of Management, Office of Policy, 
Office of Regulations and Office of Science. This Center will report 
directly to the Commissioner.
    [Part D, Chapter D-B, (Food and Drug Administration), the Statement 
of Organization, Functions, and Delegations of Authority for the 
Department of Health and Human Services (35 FR 3685, February 25, 1970, 
and 60 FR 56605, November 9, 1995, 64 FR 36361, July 6, 1999, 72 FR 
50112, August 30, 2007) is amended to reflect the restructuring of the 
Office of the Commissioner (OC), Food and Drug Administration (FDA) as 
follows].
    I. Under Part D, Food and Drug Administration, delete the Office of 
Commissioner in its entirety and replace with the following:
    DA.10 ORGANIZATION. The Food and Drug Administration (FDA) is 
headed by the Commissioner of Food and Drugs, and includes the 
following organizational units:
    Office of the Commissioner
    Office of the Chief Counsel
    Office of the Chief of Staff
    Office of Legislation
    Office of Policy, Planning and Budget
    Office of Counselor to the Commissioner
    Office of Women's Health
    Office of Special Medical Programs
    Office of External Affairs
    Office of Foods
    Office of the Chief Scientist
    Office of International Programs
    Office of Administration
    Office of Equal Employment Opportunity and Diversity Management
    Center for Tobacco Products
    DA.20 FUNCTIONS.
    Office of the Commissioner: The Office of the Commissioner (OC) 
includes the Commissioner, Principal Deputy and Deputy Commissioners 
who are responsible for the efficient and effective implementation of 
the FDA mission.
    Office of the Chief Counsel: The Office of the Chief Counsel (OCC) 
is also known as the Food and Drug Division, Office of the General 
Counsel, Department of Health and Human Services. While 
administratively within the Office of the Commissioner, the Chief 
Counsel is part of the Office of the General Counsel of the Department 
of Health and Human Services (DHHS).
    1. Is subject to the professional supervision and control of the 
General Counsel, DHHS, and represents FDA in court proceedings and 
administrative hearings with respect to programs administered by FDA.
    2. Provides legal advice and policy guidance for programs 
administered by FDA.
    3. Acts as liaison to the Department of Justice and other Federal 
agencies for programs administered by FDA.
    4. Drafts or reviews all proposed and final regulations, Federal 
Register notices and other documents prepared by FDA.
    5. Performs legal research and gives legal opinions on regulatory 
issues, actions, and petitions submitted to FDA.
    6. Reviews proposed legislation affecting FDA that applies to DHHS 
or on which Congress requests the views of DHHS.
    7. Provides legal advice and assistance to the Office of the 
Secretary on matters within the expertise of the Chief Counsel.
    Office of the Chief of Staff:
    1. Advises and provides integrated policy analysis and strategic 
consultation to the Commissioner, Principal Deputy, and Deputy 
Commissioners, and other senior FDA officials on activities and issues 
that affect significant agency programs, projects and initiatives. 
Often this function involves the most difficult problems, crisis 
situations and extremely complex issues of the agency.
    2. Provides leadership, coordination and management of the 
Commissioner's priority policies and issues across the Office of the 
Commissioner and agency wide. Identifies, triages, supervises, and 
tracks related actions from start to finish in conjunction with senior 
leadership across FDA.
    3. Serves as the principal liaison to DHHS and coordinates and 
manages activities between FDA and DHHS. Works with the FDA Centers/
Offices to ensure assignments or commitments made related to these 
activities are carried out.
    4. Provides direct support to the Commissioner, Principal Deputy, 
and Deputy Commissioners, and other FDA senior staff including briefing 
materials, background information for meetings, responses to outside 
inquiries, and maintenance and control of the Commissioner's working 
files.
    5. Provides top level leadership and guidance on issues and actions 
tied to the Agency's communications with the Public Health Service 
(PHS), DHHS, and the White House, including correspondence for 
Assistant Secretary for Health and Secretarial signatures; controls for 
all agency public correspondence directed to the Commissioner; and the 
development and operation of tracking systems designed to identify and 
resolve early warnings and bottleneck problems with executive 
correspondence.
    Executive Secretariat:
    1. Advises the Commissioner and other key agency officials on 
activities that affect agency wide programs, projects, and initiatives. 
Informs appropriate agency staff of the decisions and assignments made 
by the Commissioner, Principal Deputy and

[[Page 7492]]

Deputy Commissioners, the Chief of Staff and the Associate 
Commissioners.
    2. Develops and maintains management information necessary for 
monitoring the Commissioner's and agency's goals and priorities.
    3. Assures that materials in support of recommendations presented 
for the Commissioner's consideration are comprehensive, accurate, fully 
discussed and encompass the issues involved.
    4. Provides correspondence control for the Commissioner and 
controls and processes all agency public correspondence directed to the 
Commissioner. Develops and operates tracking systems designed to 
identify and resolve early warnings and bottleneck problems with 
executive correspondence.
    5. Provides direct support to the Commissioner, Principal Deputy 
and Deputy Commissioners, Chief of Staff and Associate Commissioners 
including briefing materials, background information for meetings, 
responses to outside inquiries, and maintenance and control of the 
Commissioner's working files.
    6. Performs agency-wide assignments involving complex problems and 
issues related to agency programs, strategies and activities, including 
preparation of special reports for the Department.
    7. Coordinates the agency's communications with the Public Health 
Service, DHHS, and the White House including correspondence for the 
Assistant Secretary for Health and Secretarial signatures.
    8. Serves as agency liaison to the Government Accountability Office 
(GAO) and the DHHS Office of the Inspector General (OIG) and 
coordinates agency engagement on GAO and OIG studies.
    Office of Legislation:
    1. Advises and assists the Commissioner and other key agency 
officials concerning legislative needs, pending legislation and 
oversight activities that affect FDA.
    2. Serves as the focal point for overall legislative liaison 
activities within FDA and between FDA, DHHS, PHS and other agencies; 
and analyzes the legislative needs of FDA and drafts or develops 
legislative proposals, position papers, and departmental reports on 
proposed legislation for approval by the Commissioner.
    3. Advises and assists members of Congress and congressional 
committees and staffs in consultation with the Office of the Secretary 
on agency actions, policies, and issues related to legislation which 
may affect FDA.
    Office of Policy, Planning and Budget:
    1. Advises the Commissioner and other key agency officials on 
matters relating to agency policy, regulations development, legislative 
issues, budget formulation, risk communication, and planning and 
evaluation activities.
    2. Provides strategic policy direction, planning, and data-driven 
analysis for FDA to more effectively and efficiently protect and 
promote public health.
    3. Develops significant and cross-cutting policy and engages in 
strategic problem solving.
    4. Serves as FDA's focal point for the development, coordination, 
oversight, and processing of regulations, guidance and other policy 
documents.
    5. Conducts economic analyses, program evaluations, and special 
studies.
    6. Leads overall FDA strategic, performance and business process 
planning, including the development of performance measures.
    7. Leads and coordinates agency-wide efforts to plan, evaluate and 
improve FDA risk communication.
    8. Leads overall FDA budget formulation and presentation.
    Office of Policy:
    1. Leads Agency wide strategic policy initiatives.
    2. Advises and assists the Commissioner and other key Agency 
officials on matters relating to agency policy, and on regulations and 
guidance development.
    3. Serves as the lead Agency focal point for developing broad 
Agency policy.
    4. Provides strategic policy direction and develops innovative 
policies for FDA to more effectively and efficiently protect and 
promote public health.
    5. Develops significant and cross-cutting policy and engages in 
strategic problem solving.
    6. Oversees, directs, and coordinates the Agency's rulemaking and 
guidance development activities.
    7. Serves as the agency focal point for communications and policies 
with regard to development of regulations and guidance.
    8. Initiates new and more efficient systems and procedures to 
accomplish Agency goals in the rulemaking and guidance development 
processes.
    9. Reviews agency policy documents to ensure consistency in 
statements regarding agency policies.
    10. Provides strategic policy direction for Agency budget 
formulation.
    11. Works with the Office of Legislation to develop, coordinate and 
provide technical assistance on legislative proposals.
    Policy Development and Coordination Staff:
    1. Leads the development of cross-cutting or broad agency policies 
and serves as a cross-Agency think tank to develop innovative policies.
    2. Advises and assists the Commissioner and other key Agency 
officials concerning information that may affect current or proposed 
FDA policies.
    3. Advises the Commissioner and other key Agency officials on the 
formulation of broad Agency policy.
    4. Engages in strategic problem solving.
    5. Serves as Agency liaison for intergovernmental policy 
development.
    6. Coordinates the development, review, and clearance of 
regulations and guidances.
    7. Manages the Agency's regulation and guidance review and 
clearance processes.
    8. Reviews policy documents to assess and achieve consistency in 
policies across documents.
    9. Establishes procedures for Agency policy formulation and 
coordinates policy formulation activities throughout the Agency.
    10. Negotiates the resolution of policy issues involving more than 
one component of the Agency.
    11. Coordinates the review and analysis of policies.
    12. Initiates and participates in interagency discussions on Agency 
regulations, plans, and policies to improve coordination of Federal, 
State, or local agencies on a specific regulation or in developing an 
effective alternative approach.
    13. Serves on Agency task forces that are critical elements in the 
initiation, study, and resolution of priority policy issues.
    Regulations Policy and Management Staff:
    1. Serves as the Agency's focal point with DHHS, Office of 
Management and Budget, and other Federal agencies for policies and 
programs concerning regulations development and for the receipt of and 
response to other Agency comments on FDA policy documents.
    2. Reviews proposed regulations, final regulations, and other 
Agency documents to be published in the Federal Register. Ensures 
regulations are necessary; consistent with established Agency policy; 
clearly written; enforceable; coordinated with other Agency components, 
the Office of the Chief Counsel, and Federal, State, and local 
government agencies; appropriately responsive to public participation 
requirements and applicable executive orders; and responsive to any 
applicable

[[Page 7493]]

requirements for assessment of economic and environmental effects.
    3. Coordinates, with other Agency components, the evaluation of 
existing regulations to determine whether they are efficiently and/or 
effectively accomplishing their intended purpose. Identifies and makes 
recommendations to address regulations that require revision to 
correspond with current standards and those that should be revoked due 
to obsolescence.
    4. Resolves regulatory policy disagreements between Agency 
components during the preparation of Federal Register documents.
    Regulations Editorial Section:
    1. FDA's official liaison within the Office of the Federal 
Register. Edits, processes, and prepares finished manuscript material 
for the issuance of Agency proposed and final regulations and other 
documents published in the Federal Register.
    2. Provides all Federal Register document development support 
functions (including cross-referencing, record retention, incorporation 
by reference, document tracking, and Agency master print books of 
current Code of Federal Regulations (CFR) materials. Controls numbering 
and organization of Agency codified material to ensure proper structure 
of regulations being issued.
    Office of Planning:
    1. Leads Agency-wide strategic planning initiatives.
    2. Advises and assists the Commissioner and other key Agency 
officials concerning the performance of the FDA planning, evaluation 
and economic analysis activities.
    3. Develops program and planning strategy through analysis and 
evaluation of issues affecting policies and program performance.
    4. Develops, installs, and monitors the Agency wide planning system 
including the long-term plans, strategic action plans, and program 
implementation plans.
    5. Leads the FDA Strategic Planning Council.
    6. Consults with and supports the Agency preparation of legislative 
proposals, budget proposals, proposed rulemaking and technical 
assistance to Congress.
    7. Conducts operations research, economic, social science and 
special studies as a basis for forecasting trends, needs, and major 
problems requiring solutions, and provides assistance and consultation 
in these areas to operating units.
    8. Evaluates impact of external factors on FDA programs, including 
industry economics, consumer expectations, and prospective legislation. 
As necessary, recommends new programs or changes in existing programs 
and program priorities.
    9. Develops FDA evaluation programs and systems to evaluate overall 
FDA program accomplishments against objectives and priorities, 
recommending changes as necessary.
    10. Estimates marginal impact of funding changes on FDA performance 
and ability to protect public health.
    11. Leads effort to analyze Agency business processes for process 
modernization and bioinformatics support.
    12. Coordinates the development of public health and program 
outcome measures, and monitors and reports on the status of those 
measures.
    13. Leads and coordinates Agency-wide effort to plan, evaluate and 
improve FDA risk communication.
    14. Leads and coordinates the Prescription Drug User Fee Act 
program initiative for Performance Management and quality systems 
studies.
    Planning Staff:
    1. Performs and coordinates the following Agency-wide performance 
planning functions:
    a. Represents the Agency in DHHS and OMB performance planning 
activities.
    b. Coordinates and reports the Agency's performance planning and 
achievements in accordance with the Government Performance and Results 
Act.
    c. Consults with the Office of Budget and collaborates with Agency 
components in preparing and reporting the performance sections of the 
Agency's budget.
    d. Coordinates the Agency long-range strategic and performance 
planning in line with the DHHS strategic plan.
    e. Maintains, analyzes and reports Agency-wide performance 
information and achievements to external stakeholders.
    2. Performs and coordinates the following Agency-wide program 
performance tracking and management functions:
    a. Coordinates the development and improvement of the Agency's 
program performance measures, data and goals on a continuous basis to 
ensure alignment to Agency's missions and objectives.
    b. Coordinates the Agency short and long range performance planning 
objectives and processes.
    c. Assists and consults with Agency components in their performance 
planning for data, trends, targets and achievements.
    d. Maintains, analyzes and reports Agency-wide quarterly program 
performance information.
    3. Performs and coordinates program advisory, planning, and 
analysis services.
    a. Assists agency components in analyzing and improving their 
planning processes, performance objectives and goals, as requested.
    b. Works with Agency components as requested to identify and 
implement internal and external best practices to improve overall 
performance.
    c. Analyzes information by applying mathematical disciplines and 
principles to make available data and facilitate improved decision-
making.
    d. Conducts special operational analysis and planning related 
studies as requested.
    e. Conducts analysis of resource requests submitted by Agency 
components and develops recommendations for the Commissioner and 
Principal Deputy Commissioner, to fulfill Agency, DHHS and OMB 
requirements.
    4. Staffs the FDA Strategic Planning Council.
    5. Provides operations analysis and project management support to 
the Agency committees and initiatives as needed.
    6. Provides operations analysis and project management support to 
the Prescription Drug User Fee program.
    Evaluation Staff:
    1. Prepares annual User Fee performance reports to Congress.
    2. Performs Agency program and policy evaluations and analytical 
studies. Recommends alternative courses of action to increase 
effectiveness of Agency allocation of resources and to improve program 
and project performance.
    3. Performs analyses of significantly broad Agency issues 
identified in the planning process. Recommends and/or implements steps 
to resolve these issues.
    4. Develops the annual evaluation plan for the Agency and 
coordinates with DHHS.
    5. Conducts special evaluations, analytical and economic-related 
studies, in support of Agency policy development and in resolution of 
broad Agency problems.
    6. Evaluates the impact of external factors on Agency programs, 
including consumer expectations and prospective legislation.
    7. Evaluates the impact of Agency operations and policies on 
regulated industries and other Agency constituents.
    8. Provides process expertise to Agency components in designing

[[Page 7494]]

consensus sessions with internal and external stakeholders.
    9. Assists and consults with Agency components on the design and 
execution of key program and process re-inventions.
    10. Assists and consults with Agency scientific review components 
to enhance transparency, consistency, accountability, and continuous 
improvement of review processes.
    11. Facilitates cross-organizational sharing of key program and 
process improvements.
    Economics Staff:
    1. Performs economic analyses and special studies for use by Agency 
officials in decisions regarding Agency policies.
    2. Serves as the Agency's chief resource for economic information.
    3. Collects and interprets economic data relevant to the Agency's 
public-health mission.
    4. Performs and reviews cost-benefit and cost-effectiveness 
analyses of Agency regulations.
    5. Advises and assists the Commissioner and other key Agency 
officials on a day-to-day basis concerning economic factors relating to 
current and proposed Agency activities.
    6. Provides economic research material for use by Agency officials 
in preparing testimony before congressional committees and in 
developing replies to inquiries directed to the Agency.
    7. Conducts economic studies of FDA-regulated industries as a basis 
for forecasting trends, needs, and major problems affecting the Agency.
    8. Provides Agency representation to Congress, OMB, DHHS, and 
others, as appropriate, on economic issues relating to Agency 
regulations and other current and proposed actions.
    Risk Communication Staff:
    1. Coordinates development of Agency policies on risk communication 
practices.
    2. Coordinates Agency strategic planning activities concerning risk 
communications.
    3. Coordinates Agency research agenda for risk communication 
methods.
    4. Facilitates development and sharing of risk communication best 
practices and standard operating procedures.
    5. Conducts risk communications research on methodological and 
cross-cutting issues.
    6. Leads management and coordination of the FDA Risk Communication 
Advisory Committee.
    7. Staffs and co-leads FDA's Communications Council.
    Business Process Planning Staff:
    1. Coordinates the Agency's business process planning function in 
support of business process improvement and automation efforts.
    2. Provides business process planning, operations analysis and 
project management support to the FDA Bioinformatics Board and its 
associated Business Review Boards.
    3. Coordinates and maintains the strategic and performance layers 
of the Enterprise Architecture, in support of the Office of Information 
Management.
    4. Establishes and maintains Agency standards for business process 
modeling.
    5. Provides business process modeling, analysis, and planning 
services to Agency programs and initiatives as needed.
    Office of Budget:
    1. Plans, organizes, and carries out annual and multi-year 
budgeting in support of FDA's public health mission and programs.
    2. Produces three major budget submissions a year DHHS in June, 
Office of Management and Budget (OMB) in September, and to Congress in 
February).
    3. Develops and presents required background exhibits, MAX input, 
and supplemental budget requests as necessary; coordinates graphic 
material for presentations; and coordinates budget passback appeals at 
each level.
    4. Coordinates appropriation hearing preparation for FDA leadership 
and conducts hearing follow-up related to transcripts, hearing 
questions and other hearing record inserts. Tracks Appropriation 
activities and bills affecting FDA resources through the legislative 
process.
    5. Responds to requests for budget information and special reports 
and exhibits.
    6. Reviews and analyzes potential budget impacts of congressional 
or administrative proposals, providing expert opinion and 
recommendations.
    7. Clears documents leaving the Agency that have budget impact or 
resource information.
    8. Tracks special initiatives and Agency cross-cutting programs.
    Office of the Counselor to the Commissioner:
    1. Formulates and renders advice to the Commissioner related to 
policy development, interpretation and integration that cuts across 
program lines or which is not well defined.
    2. Provides a leadership role in advocating for and advancing the 
Commissioner's priorities.
    3. Reviews recommendations for actions and reviews other materials 
to ensure that all points of view and program interests are developed 
for consideration and fully analyzed.
    4. Provides top level leadership for the development and management 
of emergency and crisis management policies and programs for FDA to 
ensure that a structure exists for FDA to respond rapidly to an 
emergency or crisis situation in which FDA-regulated products need to 
be utilized or deployed.
    5. Provides strategic oversight of FDA's participation in internal 
and external counter-terrorism and emergency exercises.
    6. Oversees the coordination of the Agency's evaluation of 
emergency and crisis situations to determine appropriate internal and 
external referrals for further action.
    Office of Crisis Management:
    1. Serves as the first responder for FDA in emergency and crisis 
situations involving FDA-regulated products or in situations in which 
FDA-regulated products are needed to be utilized or deployed.
    2. Assists in the development and management of emergency and 
crisis management policies and programs for FDA to ensure that a 
structure exists to respond rapidly to an emergency or crisis 
situation.
    3. Serves as Agency emergency coordinator to DHHS Office of the 
Assistant Secretary for Preparedness and Response (OASPR) and as 
liaison to DHHS Secretary's Office of Security and Strategic 
Information (OSSI). Provides OASPR situational awareness of all FDA-
related emergencies and ensures that FDA's emergency operations 
procedures are in alignment with national and DHHS procedures.
    4. Participates in international initiatives to ensure FDA's 
capability and readiness to work with foreign counterparts in 
responding to international emergencies involving or impacting FDA-
regulated products and to share information with international 
counterparts during such emergencies.
    5. Manages the FDA Emergency Operations Network Incident Management 
System (EON IMS), a system for capturing large amounts of near real 
time information about emergencies related to FDA-regulated products 
for use by senior Agency decision makers in assessing and managing 
response activities. Provides Offices and Centers geographical 
information system (GIS) maps created by EON IMS's Geographical Mapping 
System GIS mapping component for use in strategic planning of Agency 
emergency response activities.

[[Page 7495]]

    6. Develops and updates Agency emergency operations plans and 
incident specific annexes, ensuring their alignment and compliance with 
the National Response Framework (NRF) and its Emergency Support 
Functions and the National Incident Management System (NIMS).
    7. Plans and conducts Agency exercises to test emergency operations 
plans. Plans and coordinates FDA's participation in emergency exercises 
sponsored by DHHS and other Departments and agencies, including 
national and international level exercises.
    8. Develops agency training goals and initiatives to ensure that 
agency emergency response staff and senior officials are informed of 
the operational requirements of the NRF, NIMS, national level exercise 
programs and other national emergency plans and preparedness efforts.
    9. Oversees the FDA Emergency Call Center which provides after 
normal hours service for responding to public inquiries and reports 
related to FDA-regulated products as well as surge capacity service for 
managing increased volumes of inquiries due to an event involving an 
FDA-regulated product.
    10. Manages FDA's Emergency Operations Center (EOC), activating the 
EOC with augmented staffing from relevant Centers and Offices to 
monitor emergency situations, triage complaints and alerts, issue 
mission assignments to organizational components, coordinate overall 
Agency response operations, and communicate with external partners 
requesting technical and material support. FDA's EOC serves as the 
central point of contact with the Department of Homeland Security's 
National Operations Center, DHHS Secretary's Operations Center, CDC 
Emergency Operations Center, USDA/FSIS Situation Room, and other 
Federal EOCs as appropriate.
    11. Coordinates Agency evaluation of emergency responses and crisis 
situations to determine appropriate internal and external referral for 
further action and recommended changes in Agency procedures.
    12. Oversees and tests the Agency's ability to communicate through 
the Government Electronic Telecommunications Service (GETS) which 
provides global telecommunications (secure voice, facsimile and data 
communications) capability for organizations that perform national 
security and emergency preparedness functions.
    13. Oversees the work of the Office of Emergency Operations.
    Office of Emergency Operations:
    1. Serves as the Agency focal point for emergency preparedness and 
response operating the 24-hour, 7-day-a-week emergency response system.
    2. Provides support and assistance to FDA offices in managing the 
Agency's response to emergency incidents and situations involving FDA-
regulated products and disasters.
    3. Assists in the development and coordination of the Agency's 
emergency preparedness and response activities.
    4. In direct coordination with individual headquarters and field 
emergency coordination units, serves as the Agency focal point for the 
review and analysis of preliminary information about threats and 
hazards, and assists in the early recognition of emergencies, 
outbreaks, natural disasters, and terrorism or other criminal acts.
    5. Coordinates FDA emergency activities with other Federal 
agencies, State, local and foreign government officials and industry 
associations.
    6. Identifies and advocates emergency training needs for FDA 
personnel and participates in the design, implementation, and 
presentation of the training programs.
    7. Provides guidance to Agency emergency response staff in the use 
of the Incident Command System to manage single or multi-Agency 
response activities.
    8. Represents the Agency at interAgency, intraAgency, State, local 
and foreign government and industry association meetings and 
conferences on emergency preparedness and response.
    9. Manages the National Consumer Complaint System which monitors 
reports of problems with FDA-regulated products for potential 
emergencies.
    10. Participates in daily National Biosurveillance Integration 
Center conference calls sponsored by Department of Homeland Security to 
provide a secure forum for interAgency information sharing for early 
recognition of biological events of national concern, both natural and 
man-made, to make a timely response possible.
    11. Responsible for staffing the operation of FDA's Emergency 
Operations Center when activated.
    Office of Women's Health:
    1. Serves as the principal advisor to the Commissioner and other 
key Agency officials on scientific, ethical, and policy issues relating 
to women's health.
    2. Provides leadership and policy direction for the Agency 
regarding issues of women's health and coordinates efforts to establish 
and advance a women's health agenda for the Agency.
    3. Monitors the inclusion of women in clinical trials and the 
implementation of guidelines concerning the representation of women in 
clinical trials and the completion of sex/gender analysis.
    4. Identifies and monitors the progress of crosscutting and 
multidisciplinary women's health initiatives including changing needs, 
areas that require study and new challenges to the health of women as 
they relate to FDA's mission.
    5. Serves as the Agency's liaison with other agencies, industry, 
professional associations, and advocacy groups with regard to the 
health of women.
    Office of Special Medical Programs:
    1. Serves as the Agency focal point for special programs and 
initiatives that are cross-cutting and clinical, scientific, and/or 
regulatory in nature.
    2. Provides for the coordination of internal and external review of 
pediatric science, safety, ethics and international issues as mandated 
by law and Agency activities.
    3. Oversees the implementation of the orphan products provisions of 
the Federal Food, Drug and Cosmetic Act.
    4. Provides executive leadership to the Office of Good Clinical 
Practice.
    5. Oversees the functions of the Office of Combination Products as 
provided in Federal Food, Drug and Cosmetic Act.
    6. Leads Advisory Committee Oversight and Management Staff, working 
in close collaboration with all FDA Centers to provide consistent 
operations and seek continuous improvements in the Agency advisory 
committee program.
    7. Serves as the liaison on advisory committee issues with the 
Office of the Secretary, the DHHS Committee Management Office, all of 
FDA's Center advisory committee support staff, and other organizations/
offices within FDA.
    8. Ensures that all FDA committee management activities are 
consistent with the provisions of the Federal Advisory Committee Act, 
the Federal Food, Drug, and Cosmetic Act, ethics provisions in the 
criminal code, departmental policies, and related regulations and 
statutes.
    Office of Good Clinical Practice:
    1. Advises and assists the Commissioner, and other key officials on 
Good Clinical Practice (including human subject protection) issues 
arising in clinical trials regulated by the FDA that have an impact on 
policy, direction, and long-range goals.
    2. Supports and administers FDA's Human Subject Protection (HSP)/
Bioresearch Monitoring (BIMO) Council that manages and sets Agency 
policy on Good Laboratory Practices, Bioresearch

[[Page 7496]]

Monitoring, and Good Clinical Practices.
    3. Represents the Agency to other government agencies, State and 
local governments, industry, academia, consumer organizations, 
Congress, national and international organizations, and the scientific 
community on Good Clinical Practice policy issues.
    4. Provides leadership and direction on human subject protection 
and Good Clinical Practice matters and stimulates the application of 
these principles in the FDA.
    5. Evaluates the adequacy of Good Clinical Practice resources 
available to the Agency and initiates action as appropriate.
    6. Coordinates Agency policies related to the protection of human 
subjects in research, including institutional review and ethical 
considerations.
    7. Plans training programs for external use and for FDA staff on 
the Agency's Good Clinical Practice policies.
    8. Coordinates and provides oversight of Good Clinical Practice 
policy working groups developed on the recommendation of the Agency 
HSP/BIMO Council.
    9. Fosters the science of bioresearch monitoring within the Centers 
and the Office of Regulatory Affairs and coordinates for OC.
    10. Serves as the Agency coordinating point for Good Clinical 
Practice regulation, harmonization, and outreach activities.
    11. Serves as liaison between the Agency's HSP/BIMO Council and the 
Agency's Management Council.
    12. Coordinates and assists in implementation of regulations, 
policies, operational initiatives, and program priorities related to 
clinical bioresearch monitoring as developed by the HSP/BIMO Council.
    13. Monitors Agency activities and leads the development of a 
quality assurance and quality improvement program to ensure uniform 
application of clinical bioresearch monitoring policies across the 
agency.
    14. Serves as a liaison with other Federal agencies and outside 
organizations, the regulated industry, and public interest groups on 
clinical bioresearch monitoring policy and regulatory matters.
    Office of Combination Products:
    1. Serves as the Agency focal point for combination products (i.e., 
drug-device, drug-biologic, device-biologic or drug-biologic-device 
products).
    2. Serves as the Agency Product Jurisdiction Office and administers 
21 CFR part 3 (i.e., when classification or assignment is unclear or in 
dispute, classifies products as biologics, devices, drugs or 
combination products and assigns them to the Agency centers with 
primary jurisdiction).
    3. Advises the Commissioner and other key Agency officials on 
policy formulation, execution, cross-cutting and precedent setting 
issues involving combination products and involving the classification 
of products as biologics, devices, drugs, or combination products.
    4. Develops regulations, guidances, policies, procedures, and 
processes to facilitate classification and assignment of biologics, 
devices, drugs, and combination products, and to facilitate the 
Agency's regulation, review, and oversight of combination products.
    5. Reviews and updates agreements, guidance or practices specific 
to classification or assignment of products as biologics, devices, 
drugs or combination products.
    6. Serves as the focal point for employees and stakeholders to 
resolve issues arising during assignment and premarket review of 
combination products.
    7. Ensures consistency and appropriateness of postmarket regulation 
of like products to the extent permitted by law and serves as the focal 
point for employees and stakeholders to resolve issues relating to 
postmarket regulation of such products.
    8. Ensures timely and effective premarket review of combination 
products by overseeing the timeliness of Intercenter consultations and 
assisting reviews involving more than one Agency Center when necessary.
    9. Prepares annual reports to Congress on the activities and impact 
of the Office.
    Office of Orphan Products Development:
    1. Manages the implementation of the provisions of the Orphan Drug 
Act and its amendments as well as implementation of provisions of the 
statute related to humanitarian devices and pediatric devices and 
manages a program to encourage the development of drugs of limited 
commercial value for use in rare or common diseases and conditions.
    2. Develops and communicates Agency policy and makes decisions on 
approval of sponsor requests and incentives under the Federal Food, 
Drug, and Cosmetic Act, including orphan drug protocol assistance per 
section 525, orphan drug designation per section 526, orphan drug 
exclusivity per section 527, orphan drug grants and contracts to 
support clinical research and other areas of Agency policy related to 
the development of products for rare disorders.
    3. Represents the Commissioner or serves as the Agency's principal 
authority and spokesperson to governmental committees, industry, 
foreign regulatory bodies, professional organizations, patient 
advocates, and consumer associations requesting Agency participation in 
orphan product development activities.
    4. Reviews investigational new drug and biologics applications and 
investigational device exemptions to locate the existence of products 
under investigational study that show promise for effectiveness for 
rare or common diseases but lack commercial sponsorship. Assists 
sponsors, researchers, and investigators in communicating with Agency 
regulatory officials and expediting solutions to problems in obtaining 
investigational or market approval status.
    5. Manages an extramural program of clinical research and consortia 
programs to evaluate safety and effectiveness of orphan products by 
funding grants and contracts, requesting applications for funding, 
organizing peer review of applications, monitoring and guiding 
investigators, and evaluating study results.
    Office of Pediatric Therapeutics:
    1. Coordinates and facilitates all activities of the FDA that may 
have any effect on the population, the practice of pediatrics, or may 
in any way involve pediatric issues.
    2. Coordinates and communicates the review of pediatric adverse 
event reports for drugs, biologics and devices during the one-year 
period after the date of a labeling change.
    3. Provides for the review of adverse event reports and other new 
safety information and obtains recommendations from sources such as the 
Pediatric Advisory Committee (PAC) regarding whether FDA should take 
action. Additionally, OPT coordinates action by the PAC for dispute 
resolution of pediatric safety labeling changes that are not agreed 
upon by the sponsor and the Commissioner not later than 90 days after 
referral
    4. Coordinates with all DHHS and FDA employees who exercise 
responsibilities relating to pediatric therapeutics.
    5. Serves as the FDA focal point for all issues involving ethics 
and science with respect to the pediatric populations.
    6. Coordinates with the Office of International Programs while 
serving as the Agency focal point for international pediatric 
activities.
    Office of External Affairs:

[[Page 7497]]

    1. Advises the Commissioner and other key agency officials on FDA's 
communications to the media, Congress, and the general public on issues 
that affect Agency-wide programs, projects, strategies, partnerships 
and initiatives.
    2. Advises and assists the Commissioner and other key officials on 
all public information programs; acts as the focal point for 
disseminating news on FDA activities and as a liaison with the Public 
Health Service and the DHHS on public information programs.
    3. Advises the Commissioner, Deputy Commissioners and other senior 
staff throughout FDA on sensitive and controversial programs and 
initiatives that impact external stakeholder groups.
    4. Serves as a liaison between FDA and health professional and 
patient advocacy, organizations to solve problems and address concerns 
these groups have with Agency policies and programs related to human 
medical product development and safety.
    5. Coordinates and implements policies, programs and initiatives 
related to MedWatch, including the MedWatch website and e-list.
    Office of External Relations:
    1. Advises the Commissioner, Deputy Commissioners and other key 
Agency officials on Agency-level activities and issues that affect 
Agency wide programs, projects, strategies, partnerships, and 
initiatives.
    2. Advises the Commissioner, Deputy Commissioners and senior staff 
throughout FDA on sensitive and controversial programs and initiatives 
that affect external stakeholder groups.
    3. Oversees and directs the Agency's stakeholder-related 
communication functions to ensure coherence in decision making and the 
efficient operation of these functions internally and across Agency 
jurisdiction.
    4. Serves as the Agency's focal point to provide direction, 
coordination and oversight of the Agency's consumer activities and 
serves as the Agency's focal point for national consumer groups, 
academia, trade associations, ethnic and minority groups, and Tribes.
    5. Coordinates speaker requests for industry programs that cover 
multi-center issues; identifies potential conflict of interest speaker 
requests.
    6. Assists in the programmatic design, development and planning 
with internal and external organizations regarding educational and 
informational activities intended to educate regulated industry
    Communications Staff:
    1. Serves as the Agency's focal point for consumer health 
communications activities. As such, manages the consumer health 
information section of the FDA Web site, www.fda.gov.
    2. Creates and disseminates FDA consumer health information, which 
includes timely and easy-to-read articles, videos and photo slide shows 
containing the latest on all FDA-regulated products and practical 
wellness and prevention information to empower consumers.
    3. Works closely with FDA centers and offices on developing 
effective consumer health communications strategies and programs.
    4. Establishes and maintains partnerships with external 
organizations and conducts other activities to increase the reach of 
FDA consumer health information.
    5. Acts as the Agency's public information liaison with DHHS for 
all publications and audiovisual needs; provides prepublication 
clearance of publications, exhibits, and audiovisual materials in 
accordance with procedures established by the Agency, PHS, DHHS, OMB, 
and the White House.
    Office of Public Affairs:
    1. Advises and assists the Commissioner and other key officials on 
all media information activities; serves as a liaison with the Public 
Health Service and DHHS on media information activities.
    2. Serves as the Agency focal point for preparing, clearing, and 
disseminating press releases and other media statements representing 
Agency policy and responding to media inquiries; maintains liaison with 
news media.
    3. Establishes policy for and coordinates all media information 
activities, including media requests, news interviews and responses to 
inquiries; prepares position and policy statements for use by Agency 
employees in responding to media questions; tracks issues of potential 
interest to the media.
    4. Plans, develops, implements, and monitors policy and programs on 
Agency media relations, and consumer information and education programs 
conducted through the media, FDA's public affairs specialists, and 
other communications sources.
    5. Delegates Freedom of Information (FOI) denial authority to FOI 
office for the Agency.
    6. Directs the effective use of all management resources by 
coordinating the management, facilities, budget, and equipment 
resources for the Office of Public Affairs.
    7. Reviews organizational, management, and administrative policies 
of the Office to appraise the efficiency and effectiveness of 
operations.
    8. Identifies potential management problems and/or needs and plans.
    9. Advises and assists top level Agency officials on all media 
matters involving media communications.
    10. Plans, develops, and implements Agency wide multi-media 
strategies for disseminating regulatory and educational materials to 
the public through the media.
    11. Plans and coordinates all multi-media training for the Agency.
    12. Compiles and publishes to the FDA Web site the weekly FDA 
Enforcement Report; maintains the FDA Daily Clipping Service; and 
distributes the Daily Media Report to DHHS.
    Web Communication Staff:
    1. Responsible for directing the design, content management, 
usability, and evaluation of the FDA Website (www.fda.gov). Develops 
and interprets the Agency's Web policies, and serves as advocates for 
FDA's Web presence and catalysts for creative use of the Web by the 
Agency.
    2. Works closely, as partners, with the FDA Office of Information 
Management (OIM), which is responsible for the technical operations of 
FDA's Web site.
    3. Serves as the focal point and contact with the Agency, DHHS, and 
other Federal Government Web site programs and operations.
    4. Provides direction, strategic planning assistance, and 
management coordination on Agency Web site programs.
    5. Works closely with the Web site contacts in each of the Centers 
and principal offices within OC to plan, coordinate, execute and 
evaluate the Agency's Web site operations.
    6. Establishes, manages, and monitors the implementation of Agency 
standards and policies for information published on Agency Web sites.
    7. Provides Web-related information management strategy input 
through a collaborative effort with OIM and the Web site communications 
and operations staffs in the centers and OC.
    8. Designs, develops, implements, monitors, and manages information 
published on the Agency's Web site and external digital assets.
    9. Delivers the Agency's messages to the public via the Agency's 
Web site and strategic online partnerships in the government, private, 
and non-profit sectors.
    10. Directs Web 2.0 and social media services for the Agency and to 
the public.
    Office of Special Health Issues:
    1. Advises the Commissioner and other key FDA officials on matters 
related patient, patient advocacy, and health professional issues and 
concerns; serious and life-threatening diseases; minority health; and 
other special health issues

[[Page 7498]]

    2. Serves as a liaison between FDA and health professional and 
patient advocacy organizations to solve problems and address concerns 
these groups have with Agency policies and programs related to human 
medical product development and safety.
    3. Assists in the planning, administration, development, and 
evaluation of FDA policies related to patient advocacy and health 
professional organizations, serious and life-threatening diseases, and 
other special health issues
    4. Provides internal coordination on FDA activities related to 
patient advocacy and health professional organizations, serious and 
life-threatening diseases, and other special health issues.
    5. Serves as a focal point to coordinate contacts and activities 
between FDA and other Federal agencies to ensure effective coordination 
and communication regarding issues related to serious and life-
threatening diseases and other special health issues.
    6. Coordinates and implements policies, programs, and initiatives 
related to MedWatch including the MedWatch web site, and the MedWatch 
e-list.
    7. Conducts outreach and education to health professionals, 
patients and the public to facilitate the reporting of serious harm and 
injury associated with the use of human medical products.
    8. Prepares, reviews, updates, and disseminates medical product 
safety alerts and periodic safety labeling change summaries to 
patients, patient advocates, and health professionals.
    9. Informs patients, patient advocates and health professional 
organizations of upcoming public meetings, policy issues, and proposed 
rules, so that they are aware of important issues and informed of 
opportunities to comment.
    10. Assures that patient points of view are given a voice in drug 
development and policy issues that affect patient communities, through 
the patient representative and patient consultant programs.
    Office of Foods:
    1. Provides executive leadership and management to all FDA food-
related programs.
    2. Exercises, on behalf of the Commissioner, direct line authority 
over the Center for Food Safety and Applied Nutrition (CFSAN) and the 
Center for Veterinary Medicine (CVM).
    3. Exercises, on behalf of the Commissioner, all food-related legal 
authorities that the Commissioner is empowered to exercise under the 
Federal Food, Drug, and Cosmetic Act, as amended, the Public Health 
Service Act, and other applicable laws.
    4. Directs efforts to integrate the programs of CFSAN, CVM, and the 
Office of Regulatory Affairs (ORA) and thereby ensure the optimal use 
of all available FDA resources and tools to improve the safety, 
nutritional quality and proper labeling of the food supply.
    5. Directs the development of integrated strategies, plans, 
policies, and budgets to build FDA's food-related scientific and 
regulatory capacities and programs, including recruitment and training 
of key personnel and development of information systems.
    6. Represents FDA on food-related matters in dealings with the 
Office of the Secretary of DHHS, the Centers for Disease Control and 
Prevention, the U.S. Department of Agriculture, the White House and 
other elements of the executive branch.
    7. Represents FDA on food-related matters in dealings with 
Congress.
    8. In conjunction with the Office of International Programs, 
represents FDA on food-related matters in dealings with foreign 
governments and international organizations.
    9. Directs FDA efforts to build an integrated national food safety 
system in collaboration with other Federal agencies and State and local 
governments.
    10. Directs a program of public outreach and communications on food 
safety, nutrition, and other food-related issues to advance FDA's 
public health and consumer protection goals.
    Office of the Chief Scientist:
    Provides strategic leadership, coordination, and expertise to 
support scientific excellence, innovation and capacity to achieve FDA's 
public health mission. Key activities include:
    1. Fostering development and use of innovative technologies to meet 
public health needs.
    2. Supporting scientific excellence and the professional 
development of FDA scientists in all areas (i.e. population/
statistical, review, laboratory and manufacturing sciences), including 
through the Commissioner's Fellowship Program, continuing education, 
and scientific interactions with universities and others.
    3. Providing strategic leadership and support for high quality, 
collaborative, scientific activities that advance regulatory science 
and address important public health issues concerning FDA-regulated 
products, including their evaluation, quality, safety and 
effectiveness.
    4. Providing support and guidance for the National Center for 
Toxicological Research to serve as a national FDA resource for mission 
driven regulatory science.
    5. Providing cross-Agency scientific coordination (e.g., for 
emerging technologies, scientific issues involving multiple Agency 
components, standards coordination, the FDA Science Board, and science 
communication).
    6. Supporting scientific outreach, training, and collaboration, 
including research, development and Critical Path activities that 
engage other Agencies, global regulatory partners, academia, 
innovators, and consumers.
    7. Supporting science and public health activities to effectively 
anticipate and respond to counter-terrorism and emerging deliberate and 
natural threats (e.g. chemical, biological, radiological and nuclear) 
to U.S. and global health and security including through the Office of 
Counter-terrorism and Emerging Threats.
    8. Providing core scientific leadership and technical expertise, 
and ensuring Agency capacity, for advanced bioinformatics activities 
needed to support FDA programs. Serve as an Agency and government 
resource for excellence, methods development, outreach and partnerships 
in advanced bioinformatics science.
    9. Leading Agency efforts to protect and enhance scientific 
integrity, and, where substantive scientific differences of opinion 
arise and require review at the FDA level, addressing them through 
appropriate processes intended to protect both FDA's mission and the 
integrity of its science.
    Office of Counter-Terrorism and Emerging Threats:
    1. Develops and implements a comprehensive counter-terrorism 
strategy for FDA to identify and address gaps in current efforts to 
safeguard medical products from adulteration or disruption of supplies 
due to terrorist activities.
    2. Develops and coordinates the implementation of crosscutting 
policies to facilitate the availability of safe and effective medical 
countermeasures against chemical, biological, radiological, and nuclear 
agents of concern.
    3. Provides policy leadership for FDA's Emergency Use Authorization 
(EUA) activities for terrorism and public health emergencies, including 
emerging threats.
    4. Develops and coordinates the implementation of comprehensive FDA 
plans and strategies for pandemic influenza preparedness and other 
emerging threats, in collaboration with the Centers and Offices and 
with external partners.

[[Page 7499]]

    5. Provides policy leadership by promoting the goals and needs for 
counter-terrorism and other emerging threats in the Agency budgeting 
and priority-setting processes.
    6. Coordinates the portfolio of FDA counter-terrorism and pandemic 
influenza policy and planning initiatives and serves as the point of 
entry to the Agency on counter-terrorism and emerging threats policy 
and planning matters.
    7. On behalf of the Office of the Commissioner, facilitates intra- 
and interAgency communications on counter-terrorism policy and pandemic 
influenza preparedness.
    Office of Critical Path Programs:
    1. Serves as the nexus for cutting-edge, cross-center scientific 
and medical initiatives as well as policy development related to the 
Critical Path (CP) initiative and CP-related activities in the Office 
of the Commissioner.
    2. Assists the Chief Scientist in planning, executing, and 
monitoring CP-related projects, including other agencies, academia, and 
industry as identified by the Office of the Commissioner and DHHS.
    3. Performs project development, project management, and tracking, 
policy and document development and clearance, and related tasks as 
directed by the Chief Scientist.
    4. Manages Critical Path-related internal and external outreach 
(e.g., presentations, reports, videos (DVDs), pod casts, brochures, 
editorials, PR (public relations), Press kits, CPI (Critical Path 
Initiatives) Web site updates, FDA intranet) across all communications 
platforms.
    5. Supports cross-center bioinformatics activities, including 
activities related to data management and analysis and safety 
surveillance of FDA-regulated products. Supports Agency Bioinformatics 
Board and Data Councils.
    6. Coordinates administrative activities with CP (e.g., personnel, 
staffing, purchasing, and travel).
    Office of Scientific Integrity:
    1. Helps ensure consistent understanding, application and 
implementation of regulatory standards throughout FDA to ensure 
integrity and accountability of FDA functions and processes.
    2. Provides advice and guidance to the Commissioner, Chief 
Scientist, and other key officials regarding premarket approval 
processes for all FDA-regulated products including requirements 
pertaining to applications, petitions, amendments and supplements; and 
product, processing, packaging and emerging product technologies.
    3. Advises and assists senior FDA leadership in coordinating 
responses to allegations of patterns of deviations by FDA or its 
components from appropriate standards of conduct and performance. Also 
advises and assists senior FDA leadership in preventing such 
deviations.
    4. Investigates and facilitates resolution of informal complaints 
and disagreements, whether generated internally or