Federal Register / Vol. 74, No. 158 / Tuesday, August 18, 2009 / Notices 41713 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, Conference Rooms E1 & 

E2, 45 Center Drive, Bethesda, MD 20892. 

Open: September 11, 2009, 8:30 a.m. to 

adjournment. 

Agenda: For the discussion of program 

policies and issues, opening remarks, report 

of the Director, NIGMS, and other business 

of the Council. 

Place: National Institutes of Health, 

Natcher Building, Conference Rooms E1 & 

E2, 45 Center Drive, Bethesda, MD 20892. 

Contact Person: Ann A. Hagan, PhD, 

Associate Director for Extramural Activities, 

NIGMS, NIH, DHHS, 45 Center Drive, Room 

2AN24H, MSC6200, Bethesda, MD 20892– 

6200. (301) 594–4499. 

hagana@nigms.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

www.nigms.nih.gov/about/ 

advisory_council.html, where an agenda and 

any additional information for the meeting 

will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.375, Minority Biomedical 

Research Support; 93.821, Cell Biology and 

Biophysics Research; 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.862, Genetics and 

Developmental Biology Research; 93.88, 

Minority Access to Research Careers; 93.96, 

Special Minority Initiatives, National 

Institutes of Health, HHS) 

Dated: August 10, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–19663 Filed 8–17–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0376] 

Office of the Commissioner 

Reorganization; Statement of 

Organizations, Functions, and 

Delegations of Authority 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has reorganized 

the Office of the Commissioner (OC). 

This reorganization includes the 

organizations and their substructure 

components as listed in this document. 

This reorganization includes the realignment of four Deputy-level offices 

within the Office of the Commissioner: 

the Office of the Chief Scientist; the 

Office of Administration (formerly titled 

the Office of Operations); the Office of 

Foods; and the Office of Policy, 

Planning and Budget (formerly titled the 

Office of Policy, Planning and 

Preparedness). 

FOR FURTHER INFORMATION CONTACT: 

Vanessa Starks, Office of Management 

Programs (HFA–400), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6B–42, Rockville, MD 20857, 301–827– 

1463. 

Office of the Chief Scientist: The 

organizational change will allow the 

agency to better focus the science and 

research activities under the Chief 

Scientist. Re-alignments under the 

Office of the Chief Scientist will include 

the Office of Counter-Terrorism and 

Emerging Threats, Office of Critical Path 

Programs, Office of Scientific Integrity, 

and the Office of Science and 

Innovation. 

Office of Administration: The Office 

of Operations will be re-titled the Office 

of Administration. The Office of 

Administration will be restructured to 

strengthen agency wide management 

programs, budget and shared services 

operations, as well as the Office of the 

Commissioner’s executive operations. 

Realignments of the Office of 

Acquisitions and Grants Services, the 

Office of Executive Operations, the 

Office of Information Management, the 

Office of Management, the Office of 

Equal Employment Opportunity and 

Diversity Management, and the 

establishment of the Office of Financial 

Operations. 

Office of Foods: The Office of Foods 

will be realigned from the Office of 

Operations and will report directly to 

the Commissioner. 

Office of Policy, Planning and Budget: 

The Office of Policy, Planning and 

Preparedness will be retitled the Office 

of Policy, Planning and Budget. The 

realignments from the Office of Policy, 

Office of Planning, and the Office of 

Budget Formulation (formerly titled the 

Office of Budget Formulation and 

Presentation, Office of Operations). 

[Part D, Chapter D–B, (Food and Drug 

Administration), the Statement of 

Organization, Functions, and 

Delegations of Authority for the 

Department of Health and Human 

Services (35 FR 3685, February 25, 

1970, and 60 FR 56605, November 9, 

1995, 64 FR 36361, July 6, 1999, 72 FR 

50112, August 30, 2007) is amended to 

reflect the restructuring of the Office of 

the Commissioner (OC), Food and Drug 

Administration (FDA) as follows]. 

I. Under Part D, Food and Drug 

Administration, delete the Office of 

Commissioner in its entirety and replace 

with the following: 

DA.10 ORGANIZATION. The Food 

and Drug Administration (FDA) is 

headed by the Commissioner, Food and 

Drug, and includes the following 

organizational units: 

Office of the Commissioner 

Office of the Chief Counsel 

Office of the Chief of Staff 

Office of Legislation 

Office of Policy, Planning and Budget 

Office of Counselor to the 

Commissioner 

Office of Women’s Health 

Office of Special Medical Programs 

Office of External Affairs 

Office of Foods 

Office of the Chief Scientist 

Office of International Programs 

Office of Administration 

Office of Equal Employment 

Opportunity and Diversity Management 

Center for Tobacco Products 

DA.20 FUNCTIONS. 

Office of the Commissioner: The 

Office of the Commissioner (OC) 

includes the Commissioner and Deputy 

Commissioner who are responsible for 

the efficient and effective 

implementation of the FDA mission. 

Office of the Chief Counsel: The 

Office of the Chief Counsel (OCC) is also 

known as the Food and Drug Division, 

Office of the General Counsel, 

Department of Health and Human 

Services. While administratively within 

the Office of the Commissioner, the 

Chief Counsel is part of the Office of the 

General Counsel of the Department of 

Health and Human Services. 

1. Is subject to the professional 

supervision and control of the General 

Counsel, Department of Health and 

Human Services (DHHS), and represents 

FDA in court proceedings and 

administrative hearings with respect to 

programs administered by FDA. 

2. Provides legal advice and policy 

guidance for programs administered by 

FDA. 

3. Acts as liaison to the Department of 

Justice and other Federal agencies for 

programs administered by FDA. 

4. Drafts or reviews all proposed and 

final regulations and Federal Register 

notices prepared by FDA. 

5. Performs legal research and gives 

legal opinions on regulatory issues, 

actions, and petitions submitted to FDA. 


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6. Reviews proposed legislation 

affecting FDA that applies to HHS or on 

which Congress requests the views of 

the Department. 

7. Provides legal advice and 

assistance to the Office of the Secretary 

on matters within the expertise of the 

Chief Counsel. 

Office of the Chief of Staff: 

1. Advises and provides integrated 

policy analysis and strategic 

consultation to the Commissioner, 

Deputy Commissioners, and other 

senior FDA officials on activities and 

issues that affect significant agency 

programs, projects and initiatives. Often 

this function involves the most difficult 

problems, crisis situations and 

extremely complex issues of the agency. 

2. Provides leadership, coordination 

and management of the Commissioner’s 

priority policies and issues across the 

Office of the Commissioner and agency 

wide. Identifies triages, supervises and 

tracks related actions from start to finish 

in conjunction with senior leadership 

across FDA. 

3. Serves as the principal liaison to 

the Department of Health and Human 

Services (DHHS) and coordinates and 

manages activities between FDA and 

DHHS. Works with the FDA Centers/ 

Offices to ensure assignments or 

commitments made related to these 

activities are carried out. 

4. Provides direct support to the 

Commissioner, Deputy Commissioners, 

and other FDA senior staff including 

briefing materials, background 

information for meetings, responses to 

outside inquiries, and maintenance and 

control of the Commissioner’s working 

files. 

5. Provides top level leadership and 

guidance on issues and actions tied to 

the agency’s communications with the 

Public Health Service, DHHS, and the 

White House, including correspondence 

for Assistant Secretary for Health and 

Secretarial signatures; controls for all 

agency public correspondence directed 

to the Commissioner; and the 

development and operation of tracking 

systems designed to identify and resolve 

early warnings and bottleneck problems 

with executive correspondence. 

Executive Secretariat: 

1. Advises the Commissioner and 

other key agency officials on activities 

that affect agency wide programs, 

projects, and initiatives. Informs 

appropriate agency staff of the decisions 

and assignments made by the 

Commissioner, the Deputy 

Commissioners, the Chief of Staff and 

the Associate Commissioners. 

2. Develops and maintains 

management information necessary for 

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 crosscutting policy and engages in strategic 

problem solving. 

6. Oversees, directs, and coordinates 

the agency’s rulemaking and guidance 

development activities. 

7. Serves as the agency focal point for 

communications and policies with 

regard to development of regulations 

and guidance. 

8. Initiates new and more efficient 

systems and procedures to accomplish 

agency goals in the rulemaking and 

guidance development processes. 

9. Reviews agency policy documents 

to ensure consistency in statements 

regarding agency policies. 

10. Provides strategic policy direction 

for agency budget formulation. 

Policy Development and 

Coordination Staff: 

1. Leads the development of crosscutting or broad agency policies and 

serves as a cross-agency think tank to 

develop innovative policies. 

2. Advises and assists the 

Commissioner and other key agency 

officials concerning information that 

may affect current or proposed FDA 

policies. 

3. Advises the Commissioner and 

other key agency officials on the 

formulation of broad agency policy. 

4. Engages in strategic problem 

solving. 


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5. Serves as agency liaison for 

intergovernmental policy development. 

6. Coordinates the development, 

review, and clearance of regulations and 

guidances. 

7. Manages the agency’s regulation, 

guidance review and clearance 

processes. 

8. Reviews policy documents to assess 

and achieve consistency in policies 

across documents. 

9. Establishes procedures for agency 

policy formulation and coordinates 

policy formulation activities throughout 

the agency. 

10. Negotiates the resolution of policy 

issues involving more than one 

component of the agency. 

11. Coordinates the review and 

analysis of policies. 

12. Initiates and participates in 

interagency discussions on agency 

regulations, plans, and policies to 

improve coordination of Federal, State, 

or local agencies on a specific regulation 

or in developing an effective alternative 

approach. 

13. Serves on agency task forces that 

are critical elements in the initiation, 

study, and resolution of priority policy 

issues. 

Regulations Policy and Management 

Staff: 

1. Serves as the agency’s focal point 

with the Department of Health and 

Human Services, Office of Management 

and Budget, and other Federal agencies 

for policies and programs concerning 

regulations development and for the 

receipt of and response to other agency 

comments on FDA policy documents. 

2. Reviews proposed regulations, final 

regulations, and other agency 

documents to be published in the 

Federal Register. Ensures regulations 

are necessary; consistent with 

established agency policy; clearly 

written; enforceable; coordinated with 

other agency components, the Office of 

the Chief Counsel, and Federal, State, 

and local government agencies; 

appropriately responsive to public 

participation requirements and 

applicable executive orders; and 

responsive to any applicable 

requirements for assessment of 

economic and environmental effects. 

3. Coordinates, with other agency 

components, the evaluation of existing 

regulations to determine whether they 

are efficiently and/or effectively 

accomplishing their intended purpose. 

Identifies and makes recommendations 

to address regulations that require 

revision to correspond with current 

standards and those that should be 

revoked due to obsolescence. 

4. Resolves regulatory policy 

disagreements between agency 

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 agencywide effort to plan, evaluate and 

improve FDA risk communication. 

14. Leads and coordinates the 

Prescription Drug User Fee Act program 

initiative for Performance Management 

and quality systems studies. 

Planning Staff: 

1. Performs and coordinates the 

following agency’s performance 

planning functions: 

Represents the HHS in and OMB 

performance planning activities. 

Coordinates and reports the agency’s 

performance planning and 

achievements in accordance with the 

Government Performance and Results 

Act. 

Consults with the Office of Budget 

Formulation and collaborates with 

agency components in preparing and 

reporting the performance sections of 

the agency’s budget. 

Coordinates the agency long range 

strategic and performance planning in 

line with the HHS strategic plan. 

Maintains, analyzes and reports 

agency-wide performance information 

and achievements to external 

stakeholders. 

2. Performs and coordinates the 

following agency’s program 

performance tracking and management 

functions: 

Coordinates the development and 

improvement of the agency’s program 

performance measures, data and goals 

on a continuous basis to ensure 

alignment to agency’s missions and 

objectives. 

Coordinates the agency short and long 

range performance planning objectives 

and processes. 

Assists and consults with agency 

components in their performance 

planning for data, trends, targets and 

achievements. 

Maintains, analyzes and reports 

agency-wide quarterly program 

performance information. 

Performs and coordinates program 

advisory, planning, and analysis 

services. 

Assists agency components in 

analyzing and improving their planning 

processes, performance objectives and 

goals, as requested. 

Works with agency components as 

requested to identify and implement 

internal and external best practices to 

improve overall performance. 

Analyzes information by applying 

mathematical disciplines and principles 

to make available data and facilitate 

improved decision-making. 


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Conducts special operational analysis 

and planning related studies as 

requested. 

Conducts analysis of resource 

requests submitted by agency 

components and develops 

recommendations for the Commissioner, 

to fulfill agency and agency 

requirements. 

Staffs the FDA Strategic Planning 

Council. 

Provides operations analysis and 

project management support to the 

agency committees and initiatives as 

needed. 

Provides operations analysis and 

project management support to the 

Prescription Drug User Fee program. 

Evaluation Staff: 

1. Prepares annual User Fee 

performance reports to Congress. 

2. Performs agency program and 

policy evaluations and analytical 

studies. Recommends alternative 

courses of action to increase 

effectiveness of agency allocation of 

resources and to improve program and 

project performance. 

3. Performs analyses of significantly 

broad agency issues identified in the 

planning process. 

4. Recommends and/or implements 

steps to resolve these issues. 

5. Develops the annual evaluation 

plan for the agency and coordinates 

with HHS. 

6. Conducts special evaluations, 

analytical and economic-related studies, 

in support of agency policy 

development and in resolution of broad 

agency problems. 

7. Evaluates the impact of external 

factors on agency programs, including 

consumer expectations and prospective 

legislation. 

8. Evaluates the impact of agency 

operations and policies on regulated 

industries and other agency 

constituents. 

9. Provides process expertise to 

agency components in designing 

consensus sessions with internal and 

external stakeholders. 

10. Assists and consults with agency 

components on the design and 

execution of key program and process 

re-inventions. 

11. Assists and consults with agency 

scientific review components to 

enhance transparency, consistency, 

accountability, and continuous 

improvement of review processes. 

12. Facilitates cross-organizational 

sharing of key program and process 

improvements. 

Economics Staff: 

1. Performs economic analyses for use 

by agency officials in decisions 

regarding agency policies. 

2. Serves as the agency’s chief 

resource for economic information. 

3. Collects and interprets economic 

data relevant to the agency’s publichealth mission. 

4. Performs and reviews benefit-cost 

and cost-effectiveness analyses of 

agency regulations. 

5. Advises and assists the 

Commissioner and other key agency 

officials on a day to day basis 

concerning economic factors relating to 

current and proposed agency activities. 

6. Provides economic research 

material for use by agency officials in 

preparing testimony before 

congressional committees and in 

developing replies to inquiries directed 

to the agency. 

7. Conducts economic studies of FDA 

related industries as a basis for 

forecasting trends, needs, and major 

problems affecting the agency. 

8. Provides agency representation to 

Congress, OMB, HHS, and others, as 

appropriate, on economic issues relating 

to agency regulations and other current 

and proposed actions. 

Risk Communication Staff: 

1. Coordinates development of agency 

policies on risk communication 

practices. 

2. Coordinates agency strategic 

planning activities concerning risk 

communications. 

3. Coordinates agency research agenda 

for risk communication methods. 

4. Facilitates development and 

sharing of risk communication best 

practices and standard operating 

procedures. 

5. Conducts risk communications 

research on methodological and crosscutting issues. 

6. Leads management and 

coordination of the FDA Risk 

Communication Advisory Committee. 

Business Process Planning Staff: 

1. Coordinates the agency’s business 

process planning function in support of 

business process improvement and 

automation efforts. 

2. Provides business process 

planning, operations analysis and 

project management support to the FDA 

Bioinformatics Board and its associated 

Business Review Boards. 

3. Coordinates and maintains the 

strategic and performance layers of the 

Enterprise Architecture, in support of 

the Office of Information Management. 

4. Establishes and maintains agency 

standards for business process 

modeling. 

5. Provides business process 

modeling, analysis, and planning 

services to agency programs and 

initiatives as needed. 

Office of Budget Formulation: 

1. Plans, organizes, and carries out 

annual and multi-year budgeting in 

support of FDA’s public health mission 

and programs. 

2. Produces three major budget 

submissions a year (to Health and 

Human Services (HHS) in June, Office of 

Management and Budget (OMB) in 

September, and to Congress in January). 

3. Develops and presents required 

background exhibits, MAX input, and 

supplemental requests as necessary; 

coordinates graphic material for 

presentations; and coordinates 

budgetary passback appeals at each 

level. 

4. Tracks Appropriation activities and 

bills affecting FDA through the 

legislative process. 

5. Responds to numerous requests for 

budget information and special reports 

and exhibits. 

6. Reviews and analyzes potential 

budgetary impacts of congressional or 

administrative proposals, providing 

expert opinion and recommendations. 

7. Clears documents leaving the 

agency that have budgetary impact or 

resource information. 

8. Tracks special initiatives and 

agency cross-cutting programs. 

Office of the Counselor to the 

Commissioner: 

1. Formulates and renders advice to 

the Commissioner related to policy 

development, interpretation and 

integration that cuts across program 

lines or which is not well defined. 

2. Provides a leadership role in 

advocating for and advancing the 

Commissioner’s priorities. 

3. Reviews recommendations for 

actions and reviews other materials to 

ensure that all points of view and 

program interests are developed for 

consideration and fully analyzed. 

4. Provides top level leadership for 

the development of, and management of 

emergency and crisis management 

policies and programs for FDA to ensure 

that a structure exists for FDA to 

respond rapidly to an emergency or 

crisis situation in which FDA-regulated 

products need to be utilized or 

deployed. 

5. Coordinates FDA participation in 

internal and external counter-terrorism 

and emergency exercises. 

6. Implements the continuity of 

operation plans and operation of the 

emergency and the crisis operation 

center. 

7. Coordinates agency evaluation of 

emergency and crisis situations to 

determine appropriate internal and 

external referrals for further action. 

Office of Crisis Management: 

1. Serves as the first responder for 

Food and Drug Administration (FDA) in 


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emergency and crisis situations 

involving FDA regulated products or in 

situations in which FDA regulated 

products are needed to be utilized or 

deployed. 

2. Assists in the development of, and 

will manage, emergency and crisis 

management policies and programs for 

FDA to ensure that a structure exists to 

respond rapidly to an emergency or 

crisis situation. 

3. Serves as agency emergency 

coordinator to HHS Office of the 

Assistant Secretary for Preparedness 

and Response (OASPR) and as liaison to 

HHS Secretary’s Office of Security and 

Strategic Information (OSSI). Provides 

OASPR situational awareness of all 

FDA-related emergencies and ensures 

that FDA’s emergency operations 

procedures are in alignment with 

national and HHS procedures. 

Participates in OSSI intelligence 

briefings and provides secure fax 

capability for the agency. 

4. Participates in international 

initiatives to ensure FDA’s capability 

and readiness to work with foreign 

counterparts in responding to 

international emergencies involving or 

impacting FDA-regulated products and 

to share information with international 

counterparts during such emergencies. 

5. Manages the FDA Emergency 

Operations Network Incident 

Management System (EON IMS), a 

system for capturing large amounts of 

near real time information about 

emergencies related to FDA-regulated 

products for use by senior agency 

decision makers in assessing and 

managing response activities. Provides 

Offices and Centers geographical 

information system maps created by 

EON IMS’s GIS mapping component for 

use in strategic planning of agency 

emergency response activities. 

6. Develops and updates agency 

emergency operations plans and 

incident specific annexes, ensuring their 

alignment and compliance with the 

National Response Framework and its 

Emergency Support Functions and the 

National Incident Management System. 

7. Plans and conducts agency 

exercises to test emergency operations 

plans. Plans and coordinates FDA’s 

participation in emergency exercises 

sponsored by other Departments and 

agencies, including national and 

international level exercises. 

8. Oversees the FDA Emergency Call 

Center which provides after normalhours service for responding to public 

inquiries and reports related to FDAregulated products as well as surge 

capacity service for managing increased 

volumes of inquiries due to an event 

involving an FDA-regulated product. 

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 manmade, to make a timely response 

possible. 

11. Oversees and tests the agency’s 

ability to communicate through the 

Government Electronic 

Telecommunications Service (GETS) 

which provides global 

telecommunications (secure voice, 

facsimile and data communications) 

capability for organizations that perform 

national security and emergency 

preparedness functions. 

Office of Women’s Health: 

1. Serves as the principal advisor to 

the Commissioner and other key 

agency officials on scientific, ethical 

and policy issues relating to women’s 

health. 

2. Provides leadership and policy 

direction for the agency regarding issues 

of women’s health and coordinates 

efforts to establish and advance a 

women’s health agenda for the agency. 

3. Monitors the inclusion of women in 

clinical trials and the implementation of 

guidelines concerning the 

representation of women in clinical 

trials and the completion of gender 

analysis. 

4. Identifies and monitors the progress 

of crosscutting and multidisciplinary 

women’s health initiatives including 

changing needs, areas that require study 

and new challenges to the health of 

women as they relate to FDA’s mission. 

5. Serves as the agency’s liaison with 

other agencies, industry, and 

professional associations with regard to 

the health of women. 

Office of Special Medical Programs: 

1. Serves as the agency focal point for 

special programs that are cross-cutting 

and medical in nature. 

2. Manages the activities of the 

agency’s effort to ensure that medical 

products used in pediatric applications 

are properly overseen. 

3. Oversees the implementation of the 

orphan products provisions of the 

Federal Food, Drug and Cosmetic Act. 

4. Administers and manages the 

Office Good Clinical Practice. 

5. Provides executive leadership to 

the Office of Combination Products to 

ensure that appropriate jurisdictional 

decisions are made for the regulation of 

those products. 


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Office of Good Clinical Practice: 

1. Advises and assists the 

Commissioner, and other key officials 

on Good Clinical Practice (including 

human subject protection) issues arising 

in clinical trials regulated by the FDA 

that have an impact on policy, direction, 

and long-range goals. 

2. Supports and administers FDA’s 

Human Subject Protection (HSP)/ 

Bioresearch Monitoring (BIMO) Council 

that manages and sets agency policy on 

Good Laboratory Practices, Bioresearch 

Monitoring, and Good Clinical 

Practices. 

3. Represents the agency to other 

government agencies, State and local 

governments, industry, academia, 

consumer organizations, Congress, 

national and international 

organizations, and the scientific 

community on Good Clinical Practice 

policy issues. 

4. Provides leadership and direction 

on human subject protection and Good 

Clinical Practice matters and stimulates 

the application of these principles in the 

FDA. 

5. Evaluates the adequacy of Good 

Clinical Practice resources available to 

the agency and initiates action as 

appropriate. 

6. Coordinates agency policies related 

to the protection of human subjects in 

research, including institutional review 

and ethical considerations. 

7. Plans training programs for external 

use and for FDA staff on the agency’s 

Good Clinical Practice policies. 

8. Coordinates and provides oversight 

of Good Clinical Practice policy working 

groups developed on the 

recommendation of the agency HSP/ 

BIMO Council. 

9. Fosters the science of bioresearch 

monitoring within the Centers and the 

Office of Regulatory Affairs and 

coordinates for the Office of the 

Commissioner. 

10. Serves as the agency coordinating 

point for Good Clinical Practice 

regulation, harmonization, and outreach 

activities. 

11. Serves as liaison between the 

agency’s HSP/BIMO Council and the 

agency’s Management Council. 

12. Coordinates and assists in 

implementation of regulations, policies, 

operational initiatives, and program 

priorities related to clinical bioresearch 

monitoring as developed by the HSP/ 

BIMO Council. 

13. Monitors agency activities and 

leads the development of a quality 

assurance and quality improvement 

program to ensure uniform application 

of clinical bioresearch monitoring 

policies across the agency. 

14. Serves as a liaison with other 

Federal agencies and outside 

organizations, the regulated industry, 

and public interest groups on clinical 

bioresearch monitoring policy and 

regulatory matters. 

Office of Combination Products: 

1. Serves as the agency focal point for 

combination products (i.e., drug-device, 

drug-biologic, device-biologic or drugbiologic-device products). 

2. Serves as the agency Product 

Jurisdiction Office and administers 21 

CFR Part 3. (Assigns agency centers 

with primary jurisdiction for 

combination products.) 

3. Advises the Commissioner and 

other key agency officials on policy 

formulation, execution, cross-cutting 

and precedent setting issues involving 

combination products. 

4. Develops regulations, guidances, 

policies, procedures, and processes to 

facilitate the agency’s regulation, 

review, and oversight of combination 

products. 

5. Reviews and updates agreements, 

guidance or practices specific to 

assignment of combination products. 

Prepares reports to Congress on the 

activities and impact of the Office. 

6. Serves as the focal point for 

employees and stakeholders to resolve 

issues arising during assignment, 

premarket review or postmarket 

regulation of combination products. 

7. Ensures timely and effective 

premarket review by overseeing the 

timeliness of and coordinating reviews 

involving more than one agency center. 

8. Ensures consistency and 

appropriateness of postmarket 

regulation of combination products. 

9. Resolves disputes presented 

regarding the timeliness of the 

premarket review of a combination 

product. 

10. Advises the Chief Scientist on 

disputes presented regarding the 

substance of the premarket review of a 

combination product. 

11. Makes determinations as to 

whether an individual component 

product will be regulated as a human 

drug, human biologic, or human 

medical device. 

Office of Orphan Products 

Development 

1. Manages the implementation of the 

provisions of the Orphan Drug Act and 

its amendments and manages a program 

to encourage the development of drugs 

of limited commercial value for use in 

rare or common diseases and 

conditions. 

2. Develops and communicates 

agency policy and makes decisions on 

approval of sponsor requests and 

incentives under the Federal Food, 

Drug, and Cosmetic Act, including 

orphan drug protocol assistance per 

section 525, orphan drug designation 

per section 526, orphan drug exclusivity 

per section 527, orphan drug grants and 

contracts to support clinical research 

and other areas of agency policy related 

to the development of products for rare 

disorders. 

3. Represents the Commissioner or 

serves as the agency’s principal 

authority and spokesperson to the PHS 

Orphan Products Board, other 

governmental committees and industry, 

professional, and consumer 

associations, requesting agency 

participation in orphan product 

development activities. 

4. Reviews investigational new drug 

and biologics applications and 

investigational device exemptions to 

locate the existence of products under 

investigational study that show 

evidence of effectiveness for rare or 

common diseases but lack commercial 

sponsorship. Assists sponsors, 

researchers, and investigators in 

communicating with agency regulatory 

officials and expediting solutions to 

problems in obtaining investigational or 

market approval status. 

5. Manages an extramural program of 

clinical research to evaluate safety and 

effectiveness of orphan products by 

funding grants and contracts, requesting 

applications for funding, organizing 

peer review of applications, monitoring 

and guiding investigators, and 

evaluating study results. 

Office of Pediatric Therapeutics: 

1. Coordinates and facilitates all 

activities of the Food and Drug 

Administration that may have any effect 

on the population, the practice of 

pediatrics, or may in any way involve 

pediatric issues. 

2. Coordinates the review of and 

communicates internally and externally 

any report of an adverse event of a drug 

which received pediatric exclusivity. 

3. Provides for the review of adverse 

event reports and other new safety 

information and obtains 

recommendations whether FDA should 

take action. 

4. Coordinates with all Department of 

Health and Human Service and FDA 

employees who exercise responsibilities 

relating to pediatric therapeutics. 

5. Serves as the FDA focal point for 

all issues involving ethics with respect 

to the pediatric populations. 

6. Coordinates with the Office of 

International Programs while serving as 

the agency focal point for international 

pediatric activities. 

Office of External Affairs: 

1. Advises the Commissioner, Deputy 

Commissioners and other key agency 


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officials on FDA’s communications to 

the media, Congress, and the general 

public on issues that affect agency-wide 

programs, projects, strategies, 

partnerships and initiatives. 

2. Advises and assists the 

Commissioner and other key officials on 

all public information programs; acts as 

the focal point for disseminating news 

on FDA activities and as a liaison with 

the Public Health Service and the 

Department on public information 

programs. 

3. Advises the Commissioner, Deputy 

Commissioners and other senior staff 

throughout FDA on sensitive and 

controversial programs and initiatives 

that impact external stakeholder groups. 

4. Serves as an information resource 

to FDA and provides advice to the 

Commissioner and other key agency 

officials on matters related to serious 

and life-threatening diseases; patient 

advocacy, and health professional 

organizations; minority health and other 

special health issues. 

Office of External Relations: 

1. Advises the Commissioner, Deputy 

Commissioners and other key agency 

officials on agency-level activities and 

issues that affect agency wide programs, 

projects, strategies, partnerships, and 

initiatives. 

2. Advises the Commissioner, Deputy 

Commissioners and senior staff 

throughout FDA on sensitive and 

controversial programs and initiatives 

that impact external stakeholder groups. 

3. Coordinates activities involving 

emergency or crises situations and 

resolves complex problems and issues 

related to agency programs that are 

sensitive and controversial which 

impact upon agency relations with other 

Federal agencies and foreign 

governments. 

4. Oversees and directs the agency’s 

ombudsman and editorial functions to 

ensure coherence in decision making 

and the efficient operation of these 

functions internally and across agency 

jurisdictions. 

5. Provides leadership and direction 

to assure the efficient and effective 

planning, performance and evaluation 

of oversight activities. 

6. Provides direction, coordination 

and oversight of the agency’s consumer 

activities and serves as the agency’s 

focal point for national consumer 

groups. 

7. Advises the Commissioner, Deputy 

Commissioners and senior staff 

throughout FDA on sensitive and 

controversial programs and initiatives 

that impact external stakeholder groups. 

8. Serves as the agency’s focal point 

to provide direction, coordination and 

oversight of the agency’s stakeholder 

relations with national consumer 

groups, patient advocacy organizations, 

health professionals, academia, trade 

associations, ethnic and minority 

groups, and Tribes. 

9. Coordinates speaker requests for 

industry programs that cover multicenter issues; identifies potential 

conflict of interest speaker requests. 

10. Assists in the programmatic 

design, development and planning with 

internal and external organizations 

regarding educational and informational 

activities intended to educate regulated 

industry. 

Communications Staff: 

1. Identifies consumer 

communication and educational 

requirements for the agency and creates, 

implements, and coordinates 

appropriate programs conducted 

through the media, agency public affairs 

specialists, and other communication 

sources. 

2. Plans, designs, produces, publishes, 

and disseminates audiovisual materials, 

exhibits, posters, publications, and 

periodicals, including FDA Consumer; 

participates in the planning and 

development of all publications and 

audiovisual aspects of communications 

programs directed at mass audiences. 

3. Provides centralized agency graphic 

arts and editorial services for public 

information materials. 

4. Acts as the agency’s public 

information liaison with the Department 

for all publications and audiovisual 

needs; provides prepublication 

clearance of publications, exhibits, and 

audiovisual materials in accordance 

with procedures established by the 

agency, PHS, the Department, OMB, and 

the White House. 

Office of Public Affairs: 

1. Advises and assists the 

Commissioner and other key officials on 

all public information programs; acts as 

the focal point for disseminating news 

on FDA activities and as a liaison with 

the Public Health Service and the 

Department on public information 

programs. 

2. Plans, develops, implements, and 

monitors policy and programs on 

agency media relations, and consumer 

information and education programs 

conducted through the media, FDA’s 

public affairs specialists, and other 

communications sources. 

3. Plans, develops, produces, and 

publishes agency publications and 

graphic arts materials. 

4. Executes Freedom of Information 

denial authority for the agency. 

5. Directs the effective utilization of 

all management resources by 

coordinating the management, facilities, 

budget, and equipment resources for the 

Office of Public Affairs. 

6. Reviews organizational, 

management, and administrative 

policies of the Office to appraise the 

efficiency and effectiveness of 

operations. 

7. Identifies potential management 

problems and/or needs and plans, 

develops and conducts management 

studies. 

8. Coordinates speaker requests for 

industry programs that cover multicenter issues; identifies potential 

conflict of interest speaker requests. 

9. Assists in the programmatic design, 

development, and planning with 

internal and external organizations 

regarding educational and informational 

activities intended to educate regulated 

industry. 

10. Advises and assists top level 

agency officials on electronic media 

matters involving mass media 

communications. 

11. Plans, develops, and implements 

agency wide broadcast media strategies 

for disseminating regulatory and 

educational materials to the public 

through the mass media. 

12. Serves as the agency focal point 

for preparing, clearing and 

disseminating electronic media requests 

representing agency policy and 

responding to electronic media 

inquiries; maintains liaison with 

broadcast media contacts. 

13. Establishes policy for and 

coordinates all broadcast media 

information activities, including oncamera interviews and responses to 

media inquiries; prepares position and 

policy statements for use by agency 

employees in responding to broadcast 

media questions; tracks issues of 

potential interest to the media. 

14. Plans and coordinates all 

broadcast media training for the agency. 

Print Media Staff: 

1. Advises and assists top level 

agency officials on printed press matters 

involving mass media communications. 

2. Plans, develops, and implements 

agency wide print media strategies for 

disseminating regulatory and 

educational material to the public 

through the mass media. 

3. Serves as the agency focal point for 

preparing, clearing, and disseminating 

press releases and other print media 

statements representing agency policy 

and responding to media inquiries; 

maintains liaison with news media and 

pertinent publications. 

4. Establishes policy for and 

coordinates all print media information 

activities, including news interviews 

and responses to inquiries; prepares 

position and policy statements for use 


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by agency employees in responding to 

print media questions; tracks issues of 

potential interest to the media. 

5. Coordinates the research and 

drafting of major public statements by 

the Commissioner including transmittal 

documents and supportive statements 

for use in transactions with the 

Department, other agencies, and the 

White House; provides editorial 

consultation and review for 

manuscripts, articles, and speeches 

written by the staff offices serving the 

Commissioner to ensure consistency of 

information and policy interpretation. 

6. Compiles, publishes, and 

distributes the weekly FDA Enforcement 

Report and the FDA Public Calendar; 

maintains the FDA Daily Clipping 

Service; and coordinates the Daily 

Media Report. 

Web Site Management Staff: 

1. Responsible for the content and 

design of the FDA Web site 

(www.fda.gov). Develops and interprets 

the agency’s Web policies, and serves as 

advocates for FDA’s Web presence and 

catalysts for creative use of the Web by 

the agency. 

2. Works closely, as partners, with the 

FDA Office of Information Resources 

Management (OIRM), which is 

responsible for the technical operations 

of FDA’s Web site. 

3. Works closely with the Web site 

contacts in each of the Centers and 

principal offices within the Office of the 

Commissioner (OC) to plan, coordinate, 

execute and evaluate the agency’s Web 

site operations. 

4. Serves as the focal point and 

contact with the agency, Department, 

and other Federal Government Web site 

programs and operations. 

5. Provides direction, strategic 

planning assistance, and management 

coordination on agency Web site 

programs. 

6. Establishes, manages, and monitors 

the implementation of agency standards 

and policies for information published 

on agency Web sites. 

7. Provides Web-related information 

management strategy input through a 

collaborative effort with OIRM and the 

Web site operations staffs in the centers 

and OC. 

8. Designs, develops, implements, 

monitors, and manages information 

published on the agency’s Web site. 

9. Delivers the agency’s messages to 

the public through the agency’s Web 

site. 

10. Provides Web-related electronic 

information dissemination services to 

the agency and the public. 

Office of Special Health Issues: 

1. Serves as an information resource 

to FDA and provides advice to the 

Commissioner and other key agency 

officials on matters related to serious 

and life-threatening diseases; patient 

advocacy, and health professional 

organizations; minority health and other 

special health issues. 

2. Coordinates interactions between 

FDA and health professional 

organizations and patient advocacy 

groups dealing with serious and lifethreatening diseases and other special 

health issues. 

3. Serves as a focal point to coordinate 

contacts between FDA and other Federal 

agencies to ensure effective 

coordination and communication on 

serious and life-threatening diseases and 

other special health issues. 

4. Provides internal coordination on 

FDA activities related to serious and 

life-threatening diseases, patient 

advocacy and health professional 

organizations, and other special health 

issues. 

5. Assists in the planning, 

administration, development, and 

evaluation of FDA policies related to 

serious and life-threatening diseases, 

patient advocacy and health 

professional organizations, and other 

special health issues. 

Medwatch Staff: 

1. Coordinates and implements 

policies and initiatives relating to 

human medical product adverse events, 

including the MedWatch Partners 

Program, the MedWatch Web site, and 

the MedWatch e-list. 

2. Conducts outreach and education 

to health professionals, patients and the 

public to facilitate the reporting of 

serious harm and injury associated with 

the use of human medical products. 

3. Reviews, updates, and disseminates 

medical product safety alerts and safety 

labeling changes. 

Office of Foods: 

1. Provides executive leadership and 

management to all FDA food-related 

programs. 

2. Exercises, on behalf of the 

Commissioner, direct line authority over 

the Center for Food Safety and Applied 

Nutrition and the Center for Veterinary 

Medicine. 

3. Exercises, on behalf of the 

Commissioner, all food-related legal 

authorities that the Commissioner is 

empowered to exercise under the 

Federal Food, Drug, and Cosmetic Act, 

as amended, the Public Health Service 

Act, and other applicable laws. 

4. Directs efforts to integrate the 

programs of CFSAN, CVM, and the 

Office of Regulatory Affairs (ORA) and 

thereby ensure the optimal use of all 

available FDA resources and tools to 

improve the safety, nutritional quality 

and proper labeling of the food supply. 

5. Directs the development of 

integrated strategies, plans, policies, and 

budgets to build FDA’s food-related 

scientific and regulatory capacities and 

programs, including recruitment and 

training of key personnel and 

development of information systems. 

6. Represents FDA on food-related 

matters in dealings with the Office of 

the Secretary of HHS, the Centers for 

Disease Control and Prevention, the U.S. 

Department of Agriculture, the White 

House and other elements of the 

executive branch. 

7. Represents FDA on food-related 

matters in dealings with Congress. 

8. Represents FDA on food-related 

matters in dealings with foreign 

governments and international 

organizations. 

9. Directs FDA efforts to build an 

integrated national food safety system in 

collaboration with other Federal 

agencies and State and local 

governments. 

10. Directs a program of public 

outreach and communications on food 

safety, nutrition, and other food-related 

issues to advance FDA’s public health 

and consumer protection goals. 

Office of the Chief Scientist: 

1. Provides strategic leadership, 

innovation and expertise to enhance 

and support scientific excellence, 

integrity and capacity to achieve the 

Food and Drug Administration’s public 

heath mission. Key activities include: 

Fostering development and use of 

innovative technologies to meet public 

health needs, including through its 

Office of Science and Innovation, the 

Critical Path Initiative and cross-Center 

working groups. 

Supporting scientific excellence and 

the professional development of FDA 

scientists in all areas (i.e. population/ 

statistical, review, laboratory and 

manufacturing sciences), including 

through the Commissioner’s Fellowship 

Program, continuing education, and 

through relationships and staff 

exchanges with Universities and others. 

Providing strategic leadership and 

support for high quality, collaborative, 

peer-reviewed scientific activities at 

FDA that advance regulatory science 

and address important public health 

and regulatory issues concerning FDA 

regulated products, including their 

evaluation, quality, safety and 

effectiveness. This includes support for 

the National Center for Toxicological 

Research to serve as a national FDA 

resource for mission driven regulatory 

science. 

Supporting scientific outreach, 

training, collaboration in research, 

development and Critical Path activities 

that advance FDA’s mission, with other 


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Federal agencies, global regulatory 

partners, academia (e.g., through 

planned Centers of Excellence in 

Regulatory Science), innovators, and 

consumers. 

Supporting science and public health 

activities to effectively anticipate and 

respond to emerging deliberate and 

natural threats to U.S. and global health 

and security including through the 

Office of Counterterrorism and 

Emerging Threats and a planned Center 

for Innovation in Medicine and Public 

Health. 

Providing core scientific leadership 

and technical expertise, and ensuring 

agency capacity, for advanced 

bioinformatics activities needed to 

support FDA programs (e.g. scientific 

computing to allow analysis of large 

health care and safety datasets, genomic 

and other complex laboratory data, and 

simulation and modeling) . Serve as an 

agency and government resource for 

excellence, methods development, 

outreach and partnerships in advanced 

bioinformatics science. 

Leading agency efforts to protect and 

enhance scientific integrity, and, where 

substantive scientific differences of 

opinion arise and require review at the 

FDA level, addressing them through 

appropriate processes intended to 

protect both FDA’s mission and the 

integrity of its science. 

Office of Counter-Terrorism and 

Emerging Threats: 

1. Develops and implements a 

comprehensive counterterrorism 

strategy for FDA to identify and address 

gaps in current efforts to safeguard food 

and medical products from adulteration 

or disruption of supplies due to terrorist 

activities. 

2. Develops and coordinates the 

implementation of crosscutting policies 

to facilitate the availability of safe and 

effective medical countermeasures 

against chemical, biological, 

radiological, and nuclear agents of 

concern. 

3. Provides policy leadership for 

FDA’s Emergency Use Authorization 

(EUA) activities for terrorism and public 

health emergencies, including emerging 

threats. 

4. Develops and implements, in 

collaboration with the Centers and 

Offices and with external partners, 

comprehensive FDA plans and 

strategies for pandemic influenza 

preparedness and other emerging 

threats. 

5. Provides policy leadership by 

promoting the goals and needs for 

counterterrorism and other emerging 

threats in the agency budgeting and 

priority-setting processes. 

6. Coordinates the portfolio of FDA 

counterterrorism and pandemic 

influenza policy and planning 

initiatives and serves as the point of 

entry to the agency on counter-terrorism 

and emerging threats policy and 

planning matters. 

7. On behalf of the Office of the 

Commissioner, facilitates intra- and 

inter-agency communications on 

counterterrorism policy and pandemic 

influenza preparedness. 

Office of Critical Path Programs: 

1. Serves as the focus for cross-center 

scientific and medical initiatives and 

policy development related to the 

Critical Path (CP) initiative and related 

activities in the Office of the 

Commissioner. 

2. Assists the Chief Scientist in 

planning, executing, and monitoring 

projects, including, CP-related crosscenter and interagency projects and 

collaborations with other agencies, 

academia, and industry as identified by 

the Office of the Commissioner and the 

Department of Health and Human 

Services. 

3. Serves as the focus for cross center 

bioinformatics activities, including data 

management and analysis. Supports 

agency Bioinformatics Board and Data 

Councils. 

4. Performs project development, 

project management, policy and 

document development and clearance, 

and related tasks as directed by the 

Chief Scientist. 

5. Coordinates related administrative 

activities (e.g., personnel, 

communication, staffing, purchasing, 

and CP-related travel). 

Office of Scientific Integrity: 

1. Helps ensure consistent 

understanding, application and 

implementation of regulatory standards 

throughout FDA to ensure integrity and 

accountability of FDA functions and 

processes. 

2. Provides advice and guidance to 

the Commissioner, Chief Scientist, and 

other key officials regarding premarket 

approval processes for all FDAregulated products including 

requirements pertaining to applications, 

petitions, amendments and 

supplements; and product, processing, 

packaging and emerging product 

technologies. 

3. Advises and assists senior FDA 

leadership in coordinating responses to 

allegations of patterns of deviations by 

FDA or its components from appropriate 

standards of conduct and performance. 

Also advises and assists senior FDA 

leadership in preventing such 

deviations. 

4. Investigates and resolves informal 

complaints and disagreements, whether 

generated internally or externally, with 

respect to the administrative processing 

of various applications for products 

regulated by the agency as well as 

regarding the fair and even-handed 

application of agency policy and 

procedures in this process. 

5. Processes all formal appeals, or 

requests for review, that are submitted 

to the Office of the Commissioner, 

whether generated internally or 

externally, including requests for 

hearings, appeals from administrative 

actions, and requests to review 

decisions at a lower level of the agency. 

Examples include, but are not limited 

to, requests for hearings in debarment 

and disqualification proceedings, 

requests to review decisions by the 

Centers, the Office of Regulatory Affairs, 

and elsewhere in the Office of the 

Commissioner under 21 CFR 10.75, 

appeals of formal or informal hearings, 

and agency-level scientific dispute 

resolution matters. 

6. Advises and assists the Chief 

Scientist and senior leadership in 

evaluating and resolving all formal 

appeals, requests for review, and 

requests for hearings submitted to the 

Office of the Commissioner and 

coordinates responses to such appeals 

and requests. 

7. Develops regulations and 

procedures to promote an efficient and 

effective process for addressing and 

resolving formal appeals, requests for 

review, and requests for hearings, as 

well as any other types of disputes 

suitable for formal resolution in the 

Office of the Commissioner. 

8. Leads Advisory Committee 

Oversight and Management Staff, 

working in close collaboration with all 

FDA Centers to provide consistency in 

and continuously improve the 

operations of agency advisory 

committees. 

9. Serves as the liaison between the 

Office of the Secretary, the Department 

Committee Management Office, all of 

FDA’s Center advisory committee 

support staff, and other organizations/ 

offices within FDA. 

10. Ensures that all FDA committee 

management activities are consistent 

with the provisions of Federal Advisory 

Committee Act, departmental policies, 

and related regulations and statutes. 

11. Coordinates with the Office of 

Appeals, within the Office of Scientific 

Integrity, to determine whether an 

informal complaint should be construed 

and treated as a request for formal 

review by the Office of the 

Commissioner under established 

regulations or procedures. 

Office of Science and Innovation: 


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1. Provides strategic leadership, 

coordination, infrastructure and support 

for excellence and innovation in FDA 

science that will advance the agency’s 

ability to protect and promote the health 

of the public. Key activities include: 

Providing support for high quality, 

collaborative, peer-reviewed scientific 

activities throughout FDA that address 

important public health and regulatory 

issues concerning FDA regulated 

products, including their evaluation, 

quality, safety and effectiveness. 

Fostering development and use of 

innovative technologies to meet public 

health needs, including through a 

planned Center for Innovation in 

Medicine and Public Health and 

through core scientific capacity to 

support FDA’s regulatory functions and 

decision making. 

Supporting excellence and the 

professional development of FDA 

scientists in all areas (i.e. population/ 

statistical, review, laboratory and 

manufacturing sciences), including 

through the Commissioner’s Fellowship 

Program, continuing education and 

professional activities (including 

clinical activities, cross agency working 

groups, and through relationships and 

staff exchanges with Universities and 

others. 

Addressing scientific and public 

health priorities through support of high 

quality, peer reviewed scientific 

research, programs and related 

activities, both within and outside FDA 

and collaboratively, and through 

dissemination of new scientific 

information, methods and approaches. 

Supporting scientific outreach, 

training, and collaboration in research 

and development activities that advance 

FDA’s mission, including with sister 

agencies, global regulatory partners, 

academia (e.g., through planned Centers 

of Excellence in Regulatory Science), 

innovators, and consumers. 

Seeking input from both FDA 

programs, stakeholders and outside 

advisors, including the FDA Science 

Board, to help define, review and meet 

FDA scientific needs and priorities to 

support our public health mission. 

Office of International Programs: 

1. Serves as the agency focal point for 

all international matters. 

2. Serves as the primary agency 

liaison with other U.S. Government 

components, international and foreign 

governments (including Washington, DC 

embassies) for policy formulation and 

execution impacting FDA and FDA 

regulated products. 

3. Provides leadership to agency 

program areas for international 

activities. 

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 


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equal employment opportunity (EEO), 

Diversity, and Civil Rights activities 

which impact on policy development 

and execution of program goals. 

2. Serves as the agency focal point 

and liaison to the Department, other 

Federal agencies, State and local 

governments, and other organizations 

regarding EEO, Diversity, and Civil 

Rights matters. 

3. Develops and recommends policies 

and priorities designed to implement 

the intent of the Office of Personnel 

Management, Equal Employment 

Opportunity Commission, and Office of 

Civil Rights, Department of Health and 

Human Services requirements under 

Executive Orders, regulations, EEO and 

Civil Rights legislation. 

4. Provides leadership, direction, and 

technical guidance to the agency on 

EEO, Diversity, and Civil Rights matters. 

5. Examines the use and impact of 

administrative mechanisms on work 

assignments, pay systems, award 

systems, performance appraisal systems, 

promotion patterns, reorganization 

impacts, delegations of authority, 

management controls, information and 

documentation systems, and similar 

functions of management as they impact 

upon equal employment opportunities 

for all employees within the agency. 

6. Issues policies, publications and 

information dissemination services to 

agency employees including 

Commissioner Policy Statements, 

brochures, the EEO Counselors Manual, 

etc. 

Compliance Staff: 

1. Develops plans, programs, and 

procedures designed to assure the 

prompt adjudication of complaints of 

alleged discrimination based on race, 

color, sex, age, religion, national origin, 

handicap, and sexual orientation. 

2. Provides sign language interpreting 

services and manages the interpreting 

services contracts. 

Conflict Prevention and Resolution 

Staff: 

1. Provides confidential, informal 

assistance to employees and managers 

in resolving work-related concerns. 

2. Develops and coordinates effective 

resolution processes and procedures. 

3. Offers a variety of services and 

programs to address likely sources of 

conflict such as performance appraisals, 

harassment, mentoring relationships, 

and scientific collaboration. 

4. Operates as a neutral, independent, 

and confidential resource providing 

informal assistance to FDA scientists, 

administrators, and support staff in 

addressing work-related issues. Assists 

in resolving conflicts and addressing 

concerns prior to and within established 

grievances processes. 

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 Interagency Agreements (IAGs). Assigns 

Memorandum of Understanding (MOU) 

tracking number and maintains MOU 

files. 

5. Provides managerial oversight of 

the agency’s purchase card program. 

Serves as liaison with the bank, 

processing administrative functions, 

providing training and other assistance 

to ensure that participants understand 

their responsibilities under the program. 

Division of Acquisition Programs: 

1. Responsible for all information 

technology related contracts and 

simplified acquisitions related 

requirements. 

2. Provides facility support, 

construction and renovation, architect/ 

engineering services contracts and 

simplified acquisitions for all 

headquarter locations, Irvine, San Juan, 

and Dauphin Island. 

3. Provides contracts to support the 

MQSA, Food, Tissue and Medicated 

Feed/BSE Programs. These contracts 

commission the States to conduct 

inspections to ensure the quality and 

safety of the nations’ food, animal feed 

and medical devices. 

4. Responsible for simplified 

acquisitions for ORA Headquarters and 

the Office of Criminal Investigations. 

Division of Information Technology: 

1. Responsible for all information 

technology related contracts and 

simplified acquisitions related 

requirements. 

Office of Executive Operations: 

1. Develops policy and provides 

guidance, advice and oversight to Office 

of the Commissioner (OC) staff with 

regard to programmatic FDA and OC 

administrative management policies, 

procedures, and controls. 

2. Advises the Commissioner and 

other key agency officials on 


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administrative, financial and 

information management matters for 

components within the Office of the 

Commissioner (OC). 

3. Manages the OC budget formulation 

and execution activities. Provides 

advice, guidance and direction on the 

administration of the OC budget. 

4. Manages a variety of program 

administrative services including but 

not limited to travel, space, time and 

attendance, property, etc. for OC offices 

with appropriate officials. Establishes 

and maintains liaison with 

administrative staff throughout the OC 

to keep abreast of current policies and 

procedures. 

5. Serves as OC liaison for 

acquisitions and grants activities 

ensuring compliance with agency and 

Federal contracting policies. 

6. Coordinates and provides guidance 

and oversight concerning OC 

information management activities 

including those related to activities of 

FDA Bioinformatics Board. 

7. Advises the Commissioner and 

Deputy Commissioners and other senior 

staff concerning all OC human capital 

programs and activities. 

Office of Financial Operations: 

1. Plans, directs, and coordinates a 

comprehensive financial management 

operations program for FDA 

encompassing the areas of budget 

analysis, execution, automated financial 

systems, fiscal accounting, voucher 

audit, financial services related to 

accounts payable, travel support and 

payroll liaison, and financial reporting. 

Provides staff assistance in justifying 

budgets through executive and 

congressional echelons. After 

appropriation, develops an orderly 

expenditure plan. 

Office of Financial Management: 

1. Plans, directs, and coordinates a 

comprehensive financial management 

program for FDA encompassing the 

areas of budget analysis, formulation 

and execution, automated financial 

systems, fiscal accounting, voucher 

audit, and financial reporting. Provides 

staff assistance in justifying budgets 

through executive and congressional 

echelons. After appropriation, develops 

an orderly expenditure plan. 

2. Develops apportionment plans and 

issues allotments for expenditures. 

3. Makes periodic reports regarding 

the status of FDA’s financial 

management. 

4. Develops financial inputs for the 

agency’s programs and financial plans. 

Division of Accounting: 

1. Plan, evaluate and coordinate 

activities to ensure Food and Drug 

Administration (FDA) is in compliance 

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 dayto-day operations for financial services 

related to accounts payable, travel 

support and payroll liaison. 

Division of Payment Services: 

1. Performs billing and collecting 

services for headquarters accounts. 

Maintains internal control over 

processing of transactions to accounts, 

including application of batch controls 

to ensure accurate coding and making of 

necessary accounting transaction 

adjustments and corrections. 

2. Maintains liaison with the 

Department of Central Payroll on 

headquarters payroll operations. 

Reconciles payroll data with accounts. 

Maintains tax withholding files. Issues 

withholding statements. 

3. Processes employee time records; 

resolves payroll errors and assists 

employees with pay problems; issues 

new procedures as needed. 

4. Participates in reengineering the 

payroll process to streamline correction 

of errors and reduce first time errors; 

and participates in timekeeper training. 

5. Processes all purchase orders, 

receiving reports, and invoices for 

commercial payments made by the Food 

and Drug Administration (FDA) 

headquarters, assuring compliance with 

accounts and the Prompt Pay Act. 

6. Coordinates with vendor and center 

personnel in researching payment 

information. 


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7. Responds to all vendor inquiries as 

well as inquiries from center personnel. 

8. Prepares various reconciliations to 

ensure that schedules are properly 

accounted for and entered into the 

accounting system. 

9. Reviews and distributes monthly 

accounting reports and processes 

corrections, as necessary. 

10. Liaison with the Department of 

Treasury to initiate check traces. 

Division of Travel Services: 

1. Oversees processing of vouchers, 

including audit, matching with 

obligations, and scheduling for direct 

deposit using Travel Manager Software. 

2. Oversees post audit of travel 

vouchers. 

3. Provides travel advice/guidance 

throughout the agency, including 

significant research on Comptroller 

General Decisions; participates in 

training on travel procedures. 

4. Oversees contractor processing of 

all headquarters and field Permanent 

Change of Station travel vouchers, 

including complex tax calculations. 

5. Coordinates with the General 

Services Administration (GSA) 

contractual travel agent to ensure the 

Food and Drug Administration (FDA) 

travel and transportation requirement 

are met. 

6. Field activities perform travel 

services directly for ORA and NCTR to 

include NCTR travel, ORA international 

travel, FATA responsibilities, data calls, 

travel audits, 348 travel and conference 

reporting. 

Office of Information Management: 

1. Develops the architecture, 

standards, policies, governance, best 

practices and technology road map that 

support the business priorities of the 

agency, including managing information 

technology infrastructure, 

telecommunications, security, strategic 

planning, capital planning and 

investment control, enterprise 

architecture, and applications 

development and; management. 

Provides advice and assistance to the 

Commissioner and senior management 

officials on information technology 

resources and programs. 

2. Establishes and oversees 

implementation of the Food and Drug 

Administration (FDA) information 

technology policy and governance, 

procedures and processes to bring the 

agency in conformance with the 

Clinger/Cohen Act and the Paperwork 

Reduction Act. Provides leadership and 

direction regarding all aspects of the 

agency records management program. 

3. Works in full partnership with FDA 

business areas, develops and 

communicates the overall vision for the 

agency’s IT program. 

4. Provides expert technical 

evaluation and recommendations for the 

new and emerging technologies to 

ensure the agency’s IT program can 

proactively adjust to changing business 

needs and technology drivers. 

5. Represents the agency IT program 

on internal and external meetings and 

workgroups on agency information 

technology programs and issues (e.g., 

Health and Human Services (HHS) Chief 

Information Officer (CIO) Council, FDA 

Leadership council, FDA level Review 

boards, etc.). 

6. Establishes policies and procedures 

for system risk assessments and system 

business continuity and contingency 

planning. 

Division of Business Partnership 

Support: 

1. Advocates, communicates, 

provides, and manages liaison services 

and provides management and technical 

consultation resources regarding 

information technology to FDA offices, 

centers and other FDA stakeholders, 

including parties external to FDA (nongovt, e.g., PHRMA, BIO, DIA, ICH, etc) 

and PHS, Department, and other Federal 

government IRM and ADP operations. 

2. Collaborates with BIB and the BRBs 

to prioritize new business requirements 

and establish projects which will 

require PM’s and designs, develops and 

maintains the communication plan for 

all Enterprise agency projects the BIB, 

BRBs, and OIM. 

3. Collaborates with other divisions 

within OIM to review request for each 

system; providing estimates for 

implementation and to assist in the 

establishment of priorities and 

schedules (overarching timeline of all 

projects/independencies), as well as 

ensure project/investment formulation, 

execution and actual information is 

reported. 

4. Oversees and manages IT program 

and project management activities of 

major IT initiatives following project 

management best practices (Project 

Management, System Development, and 

Enterprise Program life cycles), in 

collaboration with the Division of CIO 

Support/Governance Branch, develops 

policies and procedures on all aspects of 

project planning, and interacts with and 

coordinates responses to the Department 

and OMB on all project management 

related activities. 

5. Coordinates development of 

Center/Offices IT budget and provides 

support for budget execution and 

contract monitoring of information 

resources. 

6. Oversees day-to-day operations of 

FDA web development, redesign, and 

web hosting environment. 

7. Manages FDA Forms programs and 

is the lead for agency Section 508 

implementation. 

8. Receives user requests, orders, and 

issues desktop-related tools and 

equipment. 

9. Manages and oversees help desk 

services and user support for 

infrastructure Center and/or FDA-wide 

applications (excludes field help desk 

which is part of the Division for 

Infrastructure Operations). 

Division of Chief Information Officer 

Support: 

1. Establishes and maintains an 

agency Enterprise Architecture (EA) 

governance structure that includes 

processes for systems, business, data, 

applications, technology, and security 

architectures. 

2. Serves as a focal point within FDA 

and as a liaison between FDA and 

external public and private sector 

organizations regarding enterprise 

standards, IT architecture, investment 

management practices and related 

methodologies, data sharing and 

support services, and regarding all 

aspects of IT planning, development 

and management. 

3. Develops, tracks and maintains the 

IT budget, operating plan, and 

acquisition plan. Manages and 

maintains an acquisition strategy policy 

and implements all aspects of contract 

administration and management for the 

Office of Information Management. 

4. Plans, organizes and manages 

FDA’s IT investment management 

process (CPIC) to ensure that IT 

resources are acquired and managed 

effectively, and to ensure effective 

ongoing control of IT investments. 

Additionally, architectural reviews of IT 

investments are conducted to ensure 

alignment with business functions, 

avoid duplication of effort, reduce costs, 

and improve the efficiency and 

effectiveness of IT initiatives and to 

ensure that the FDA IT enterprise 

employs appropriate standards. 

5. Coordinates the agency IT risk 

management program, including 

identification, analysis, and mitigation 

and reporting of program and system 

level weaknesses. The division also 

maintains and audits compliance for 

system risk assessments and system 

business continuity and contingency 

planning. 

6. Establishes administrative policies 

for OIM consistent with agency policies 

and manages all administrative 

activities including Administrative 

Support, Travel and Timekeeping. 

7. Develops, maintains and manages 

the electronic records (e-records) policy 

within the Office of Information 

Management and coordinates as 


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necessary with other business entities 

within the FDA on records management 

activities. 

8. Provides management of all aspects 

of human capital in the recruitment, 

hiring, deployment, development, 

management, training and evaluation of 

the OIM workforce to ensure that 

human capital programs are aligned 

with organizational goals and agency 

Human Resource requirements. 

9. Develops and disseminates 

administrative internal communications 

and operational procedures for the OIM 

in coordination with the 

Communications Team. Keeps abreast of 

agency and office rules, regulations, 

procedures, policies and decisions 

Division of Systems Management: 

1. Designs, develops, implements, and 

maintains all agency software 

applications, IT systems, systems 

support and maintenance, and their 

integration with other Federal agencies, 

State and foreign governments and 

public and private entities. 

2. Establishes and implements an 

Enterprise IT Common Component 

Framework containing modules/services 

to be shared across FDA information 

systems and maintains FDA enterprise 

applications through effective 

evaluation, streamlined application 

development, monitoring, testing, and 

control of agency-wide systems utilizing 

e-platform initiatives and 

interchangeable common components in 

order to support FDA business process 

needs and objectives efficiently and 

effectively. 

3. Validates requirements for and 

directs the design, development and 

implementation of new system 

requirements, system enhancements and 

system maintenance changes for the 

agency, performs systems analyses to 

develop and implement testing 

strategies, procedures and 

methodologies, especially automated 

varieties, and develops and implements 

system specifications, requirements, 

procedures and guidelines. 

4. Designs, develops, implements, and 

maintains standards-based electronic IT 

data systems and repositories that 

provide the FDA with an integrated and 

interoperable information environment 

to receive, track, analyze, and 

disseminate knowledge on FDA 

business/program activities and directs 

the development and implementation of 

FDA Data Administration policies 

standards and procedures to ensure 

design consistency, including review of 

work products for compliance with 

standards. 

5. Assists in the development and 

implementation of technical 

specifications and plans for 

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: 


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1. Advises and assists the 

Commissioner, Deputy Commissioner, 

Associate Commissioners and other key 

agency officials on various management 

and systems activities. 

2. Assures that the conduct of agency 

administrative, personnel, organization, 

and similar support activities effectively 

support program operations. 

3. Provides leadership and direction 

regarding all aspects of a variety of 

agency management programs, 

including ethics, dockets management, 

organization management, delegations 

of authority and special studies and 

projects for the Office of the 

Commissioner. Establishes agency-wide 

policy and provides overall direction 

and leadership for the Freedom of 

Information (FOI) program and Privacy 

Act program. 

4. Integrates the agency’s technical, 

programmatic and facilities 

requirements into the overall budgetary 

and development plan for the agency’s 

consolidation. Implements relocation 

planning needed to successfully 

transition the agency into its new 

location. 

5. Provides Food and Drug 

Administration’s administrative services 

and facilities. Utilizes a call center to 

address all administrative and 

information technology management 

issues, and monitors and analyzes 

operational and customer satisfaction. 

6. Provides leadership and direction 

regarding all aspects of agency-wide 

human resources management including 

employment, recruitment, training, 

career development, partnership 

activities, quality of work life issues, 

and executive services. 

7. Provides program, technical and 

resources management for the FDA 

White Oak consolidation, logistics and 

facilities operations and maintenance 

services. 

8. Provides leadership and guidance 

to the agency for all aspects of physical 

and personnel security including the 

suitability and National Security 

Information Program. Develops and 

implements agency wide security 

policy. 

9. Manages and administers the 

suitability and security program as 

required by the Office of Personnel 

Management as set forth in ‘‘Suitability’’ 

(5 CFR, Part 731), and ‘‘National 

Security Positions’’ (5 CFR, Part 732). 

Monitors the appropriate security 

clearance levels for agency positions, 

employees, and contract employees. 

10. Processes clearance requests, 

reviews investigative reports/findings 

and makes suitability determinations 

based on investigative findings. 

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 


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operation and effectiveness of FDA 

resulting in productivity and efficiency 

gains. 

Provides agency-wide leadership and 

guidance for all aspects of physical and 

personnel security including the 

Suitability and National Security 

Information program. 

Develops and implements agency 

wide security policy. 

Office of Management Programs: 

1. Provides leadership and direction 

regarding all aspects of a variety of 

agency management programs, 

including strategic human capital, 

organization management, delegations 

of authority, competitive sourcing, 

executive resources management, 

performance management, rewards and 

recognition, workforce development and 

succession planning, and special studies 

and projects for the Office of the 

Commissioner. The following are 

specific functions within the Office: 

Provides management analysis 

support and advisory services to the 

Office of the Commissioner and other 

agency components. 

Serves as the agency focal point for 

FDA’s organizational management and 

delegations of authority program, 

including monitoring of the 

establishment, abolishment, 

modification, transfer or consolidation 

of agency organizational components 

and their functional statements, and 

administering the Standard 

Administrative Code (SAC) system. 

Provides direction and oversight for 

the agency’s Competitive Sourcing 

Program, including the development of 

the FAIR Act Inventory, evaluating the 

efficiencies of the Most Efficient 

Organization, establishing policies, and 

advising senior leadership. 

Manages the agency’s human capital 

program, ensuring that human capital 

management programs are merit-based, 

effective, efficient and supportive of 

mission goals; alignment of human 

capital strategies with agency mission/ 

goals; assessing workforce staffing 

needs; ensuring continuity of effective 

leadership to manage programs and 

achieve goals; and identification of 

mission-critical competency gaps and 

strategies to close the gaps and hire/ 

retain necessary talent. 

Provides leadership, direction, policy 

development, and oversees the 

performance management programs 

covering the Senior Executive 

Performance Management Program and 

the Performance Management Appraisal 

Program. 

Provides leadership, direction, policy 

development and program management 

for agency workforce and succession 

planning activities. 

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 agencywide physical security programs and 

provides professional leadership and 

authoritative guidance. 

9. Provides physical, documentary, 

and preventative security consultation 

to FDA components. 

10. Formulates policy and procedures 

necessary to maintain the integrity of 


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privileged and trade secret information 

submitted by industry. 

11. Develops and manages the 

agency’s contractor security program 

when Automated Data Processing 

services or non-public information is 

released under contract agreement. 

Office of White Oak Services: 

1. Provides program, technical and 

resources management for the Food and 

Drug Administration (FDA) White Oak 

consolidation, logistics and facilities 

operations and maintenance services. 

2. Provides leadership and guidance 

to FDA Headquarters’ staff offices and 

Headquarters operating activities for 

White Oak services. 

3. Directs building operations 

functions for all FDA facilities at the 

White Oak Campus. 

4. Provides direct interface with the 

General Services Administration (GSA) 

for White Oak services. 

5. Serves as liaison with the 

Department of Health and Human 

Services (DHHS) and GSA for the 

efficient management and operation of 

facilities occupied by FDA programs at 

White Oak. 

6. Directs and manages over a $70 

million appropriation for the operation, 

construction, relocation, and 

maintenance for the White Oak Campus. 

7. Provides leadership and direction 

to assure the efficient and effective 

utilization of FDA’s resources dedicated 

to engineering design, facility 

improvements, and new construction of 

FDA facilities at White Oak. 

8. Furnishes project management 

services including project planning, cost 

estimating and design, and oversight of 

construction until completion. 

9. Ensures meaningful and continuous 

communication with community 

leaders and associations, other Federal 

officials, State and local governments, 

and business leaders and customers at 

White Oak. 

10. Develops multiple strategies for 

addressing FDA’s long and short-range 

facility plans at White Oak. 

11. Develops agency plans, policy and 

procedures consistent with new 

regulatory requirements and agency 

needs for White Oak. 

Division of Logistics Services and 

Facilities Operations: 

1. Manages shared use conference and 

training facilities at the White Oak 

Campus. 

2. Oversees transportation 

management programs and services, 

serves as the inter-governmental liaison 

on transportation issues, manages 

parking, ridesharing program, shuttle 

services, fleet management and motor 

pool management. 

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, 


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coordinate, determine policy, and 

provide oversight for the provision of 

services and information, in a variety of 

formats and for a variety of purposes, to 

FDA and the public for the services 

provided by the Dockets Management 

Branch (DMB) and the Freedom of 

Information Branch (FOIB). 

The following are specific functions 

within the Office: 

Provides leadership and direction for 

the operations of the agency information 

centers, including the FOIB and DMB 

public reading rooms. 

Provides executive perspective on 

current policy objectives and increases 

public understanding of the agency’s 

purpose and function. 

Establishes agency-wide policy and 

provides overall direction and 

leadership for the Freedom of 

information (FOI) and Privacy Act 

programs. 

Provides information and support to 

FDA through access to various 

documents via consulting and advisory 

services, and through proactive posting 

to the FDA internet. 

Provides leadership and direction 

regarding all aspects of the agency’s 

regulated dockets program. 

Dockets Management Branch: 

1. Receives, examines and processes 

submissions required or permitted in 

agency administrative proceedings; 

establishes and maintains docket files 

containing agency official records 

relating to an administrative proceeding. 

Disseminates submissions to 

appropriate offices for action. Routinely 

coordinates activities of the branch with 

other appropriate components. 

2. Serves as the agency expert on 

requirements for submissions required 

or permitted in agency administrative 

proceedings. Participates in the 

development of regulations and policy 

impacting on agency administrative 

proceedings and the release of 

information under the Freedom of 

Information Act (FOIA). 

3. Provides staff support for agency 

rulemaking activities. Determines 

compliance of petitions, comments, 

request for hearings, motions, briefs, 

and objections with agency regulations. 

4. Establishes agency-wide policy and 

provides overall direction and 

leadership for the Freedom of 

information (FOI) and Privacy Act 

programs. 

5. Maintains and operates a public 

reading room to make agency official 

records available to any interested party, 

and provides copies upon request, 

under the provisions of the FOIA. 

6. Provides electronic access to these 

records, via the Internet, and other 

means, as required by the EFOIA. 

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 


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searches and delivery of customized 

information packages. 

6. Provides articles and documents to 

researchers via document delivery and 

inter-library loan services. 

7. Monitors and administers the 

document delivery system, ILLiad, and 

the customer relationship management 

system, Ask a Librarian. 

8. Interprets library and information 

policy and copyright guidance for FDA 

customers. 

9. Manages and coordinates access to 

bibliographic citation management 

systems, Reference Manager and 

EndNote, and consultants with 

researchers to assist with preparation of 

bibliographies and citations. 

10. Delivers presentations and 

briefings at New Employee Orientations, 

Awareness Days, Open Houses, and 

FDA center events to promote the 

library resources and services. 

Technical Services Branch: 

1. Ensures the library collections, both 

online and in print formats, are 

responsive to customer research and 

information needs. 

2. Manages portfolio of the library’s 

research resources. 

3. Develops and implements the 

library’s collection development policy 

and interprets policy to customers to 

justify purchase decisions, collection 

scope and other criteria. 

4. Collects usage data, customer 

recommendations and feedback to 

determine information resources to 

maintain and to cancel; administers 

acquisition of print and online 

resources. 

5. Establishes site licenses beneficial 

to FDA research for all library 

subscribed electronic resources. 

6. Establishes pilot tests to evaluate 

new electronic information resources; 

analyzes feedback and makes 

determinations for purchase decisions. 

7. Administers the integrated library 

system and its modules, including the 

online public access catalog, the 

federated search engine, and the 

electronic resource management system. 

8. Provides news pushes including 

the Federal Register, and manages 

listservs to provide daily email updates 

to online newsletters of interest. 

FDA History Office: 

1. Provides expertise on the history of 

FDA and its predecessors; is a key 

resource for historical records and 

resources used for agency 

commemoratives, anniversaries and 

milestones. 

2. Responds to information requests 

from FDA centers, scholars, the press, 

consumers, government agencies, 

industry, trade organizations, health 

professionals, associations, and foreign 

sources. Presents information in 

workshops, briefings, and seminars. 

3. Conducts research and produces 

publications, briefing reports, and 

presentations interpretive of FDA. 

Maintains an extensive office research 

file. 

4. Provides expertise and assesses the 

historical value of agency resources, i.e., 

records, photographs, films, audiovisual records, and rare or out-of-print 

monographs. Leverages FDA resources 

through consultative partnerships with 

FDA offices. Collaborates on 

preservation of historical materials with 

experts at the National Archives and 

Records Administration, the National 

Library of Medicine, the Smithsonian 

Institution, and other government, 

academic, and private institutions. 

5. Collects, processes, and preserves 

artifacts that capture the history of 

FDA’s work, represent the commodities 

it regulates, and document the breadth 

of its responsibilities. Mounts a variety 

of exhibits in collaboration with other 

public and private institutions to 

educate agency employees and the 

public about the history and work of the 

FDA. 

6. Partners with the National Library 

of Medicine, History of Medicine 

Division, to create and make available 

transcripts and recordings of an oral 

history program that documents FDA’s 

institutional history, through personal 

interviews with key exiting FDA 

employees. 

Office of Real Property Services: 

1. Provides leadership and guidance 

to agency components for all aspects of 

real property management functions. 

2. Directs the management of 

programs and systems leading to the 

acquisition, alteration, maintenance, 

and utilization of leased and owned 

facilities nationwide, except for the 

acquisition of buildings for the White 

Oak Headquarters Consolidation. 

3. Directs building operations 

functions for all Food and Drug 

Administration (FDA) facilities 

nationwide. 

4. Manages the program and provides 

direct interface with General Services 

Administration (GSA) for lease 

acquisition and lease management for 

all agency facilities nationwide. 

5. Serves as liaison with the 

Department of Health and Human 

Services (DHHS) and GSA for general 

facilities management issues and 

specifically for the efficient 

management and operation of facilities 

occupied by FDA programs nationwide. 

6. Directs and manages an excess of 

$221 million dollar appropriation for 

the acquisition, operation, construction, 

maintenance for the agency’s 

nationwide real property portfolio. 

7. Provides leadership and direction 

to assure the efficient and effective 

utilization of FDA’s resources dedicated 

to engineering design, facility 

improvements, and new construction of 

FDA facilities nationwide. 

8. Establishes management structure 

and dialog with GSA and the 

architectural engineering design and 

construction contractors to ensure FDA 

program needs and concerns are fully 

addressed. 

9. Ensures meaningful and continuous 

communication with community 

leaders and associations, State and local 

governments, and business leaders in 

areas where FDA proposes new 

facilities. 

10. Develops and implements 

program plans, policies and procedures 

designed to create and maintain a safe 

and healthful environment for FDA 

employees, visitors, and guest workers, 

and to protect the environment. 

11. Develops agency plans, policy and 

procedures consistent with new 

environmental health and safety 

regulatory requirements and agency 

needs. Provides fire protection, safety 

engineering, and environmental health 

consultation to the agency’s program 

managers and engineering offices. 

12. Leads the agency’s 

decommissioning efforts to close FDA 

laboratories and offices from an 

environmental, safety and health 

perspective. 

13. Consults with program officials on 

safety matters pertaining to changing 

and emerging research programs. 

14. Recommends special technical 

studies to increase the knowledge of the 

relationship between occupational 

safety and environmental health and 

laboratory programs of FDA. 

15. Provides support to the FDA 

Safety Advisory Board and conducts the 

FDA Safety and Health Council 

meetings. 

16. Develops and implements a safety 

management quality assurance program 

for the agency’s multiple work sites 

nationwide. Develops and implements a 

similar headquarters program consistent 

with the FDA Safety Advisory Board 

recommendations and approval. 

Jefferson Laboratories Complex Staff: 

1. Provides leadership and direction 

regarding all aspects of facilities 

management. 

2. Manages and coordinates all 

aspects of the Jefferson Laboratories 

long range facilities planning. 

3. Develops renovation and 

improvement project definitions and 

priorities for inclusion in the agency’s 

Annual Facilities Plan and budget. 


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4. Provides leadership and direction 

to assure the efficient and effective 

utilization of Jefferson Laboratories 

resources dedicated to engineering 

design, facility improvements, 

maintenance and new construction 

projects. 

Division of Engineering Services: 

1. Manages and directs design and 

construction requirements for facility 

acquisitions within the agency. These 

requirements may encompass the 

following activities singularly or in 

combination; preparation of proposals, 

preparation of functional requirements, 

program of requirements and criteria, 

architect and engineering liaison, space 

design and planning, functional and 

technical reviews, preliminary site 

selections, and project management for 

facilities construction, renovation and 

improvement projects. 

2. Provides engineering guidance and 

support for all activities related to 

maintenance, alterations, and repairs for 

agency facilities nationwide. 

3. Directs and coordinates all agency 

facilities programs concerned with 

equipment specifications and 

installation associated with facility 

acquisitions. Assists the programs’ staffs 

in developing compatible facilities and 

equipment systems for the agency. 

4. Provides overall engineering 

services including: feasibility studies, 

design criteria, concept, analysis, and 

estimates. Schedules and tracks 

building and facilities projects and 

manages project design. 

5. Manages the FDA energy 

management program; develops agency 

policy relating to the program; develops 

and enforces supporting agency 

standards that comply with stated goals 

of the Department. 

6. Oversight of structural, 

architectural or mechanical 

modifications to accommodate specific 

requirements in the existing FDA 

portfolio. 

7. Prepares computer—aided design 

(CAD) drawings for the agency and 

maintains file of master drawings for 

FDA portfolio. 

8. Administers agency contract for 

renovations/alterations of office space. 

9. Provides space and alterations 

project management for existing FDA 

space to program components. 

10. Develops, implements and 

manages integration of facilities 

technologies. 

Environment, Safety and Strategic 

Initiatives Staff: 

1. Manages the agency’s Environment, 

Safety and Health (EH&S) Program; 

2. Oversees strategic management 

initiatives and programs initiated at 

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. 


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4. Establishes and manages a program 

to maintain the highest level of quality 

and integrity for all Center laboratory 

studies and the processing of regulatory 

samples, and ensures that all 

laboratories are in compliance with 

Good Laboratory Practice Regulations. 

5. Coordinates and monitors the 

Center’s overall research portfolio, 

including all research-related activities 

and inquiries and the development of 

strategic research program plans. 

6. Serves as the primary 

representational role for relationships 

with the department, OMB, the White 

House, the Congress and the media. 

Office of Management: 

1. Provides support to the Center 

Director and Deputy Directors, 

including the coordination and 

preparation of briefing materials and 

background information for meetings, 

responses to outside inquires, and 

maintenance and control of the Center 

Director’s working files. 

2. Manages the Center’s Freedom of 

Information Act activities, coordinating 

responses with other Center technical, 

regulatory, and policy units as well as 

developing direct responses. 

3. Provides correspondence control 

for the Center and controls and 

processes all agency public 

correspondence directed to the Center 

Director. Develops and operates tracking 

systems designed to identify and resolve 

early warnings and bottleneck problems 

with executive correspondence. 

4. Coordinates the Center’s 

communications with the agency, 

Department, and the other Federal 

government agencies. 

5. Provides authoritative advice and 

guidance to the Center Director on 

management policies, guidelines, issues 

and concerns that directly impact 

Center programs and initiatives. 

6. Provides leadership, guidance and 

directs the development of long-range 

strategic and operational plans and 

systems for Center activities and directs 

technical support staff in providing 

essential management services and 

other critical support functions. 

7. Provides leadership and guidance 

as primary interface working with the 

FDA Office of Shared Services to ensure 

provision of a broad range of essential 

technical support services. 

8. Provides leadership and effective 

coordination as the primary Center 

liaison and expert with the Office of 

Information Management for provision 

and continuous improvement of 

information and technology services for 

the Center to include networking, 

scientific computing software 

engineering, systems, and 

telecommunications. 

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 FederalState program and policy; coordinates 

the program aspects of agency contracts 

with State and local counterpart 

agencies. 

Office of Science: 

1. Serves as principal authority and 

provides leadership for the Center’s 

participation in the National Toxicology 

Program (NTP). 

2. Organizes, plans, and directs Center 

research programs in accordance with 

Center-wide strategic direction. 

Implements Center-wide strategies for 

achieving annual and long-range plans 

for research. 

3. Provides leadership and direction 

for communications among scientific 

and administrative staffs. 


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4. Organizes, plans, and directs the 

Center for research support in the areas 

of Tobacco. 

Directs the development methods 

used to extrapolate test results from 

animals to humans. 

5. Coordinates research in Center 

program areas with leading scientists in 

other segments of FDA and the scientific 

community at large and promotes and 

coordinates the Center’s technology 

transfer under the provisions of the 

Federal Technology Transfer Act. 

6. Coordinates with other Center and 

agency components and top level 

officials of other agencies to provide 

input for long-term research planning in 

responsible program areas. 

7. Insures that programs implemented 

are responsive to the Center’s portion of 

the agency’s integrated research plan. 

8. Provides scientific oversight of 

Center research contracts and 

agreements. 

9. Advises and assists the Center 

Director, Deputy Director, and other key 

officials on scientific issues that have an 

impact on policy, direction, and longrange goals. 

10. Coordinates and provides 

guidance on special and overall science 

policy in program areas that cross major 

agency component lines and scientific 

aspects that are critical or controversial, 

including agency risk assessment 

policies. 

11. Represents the Center with other 

government agencies, state and local 

governments, industry, academia, 

consumer organizations, Congress, 

national and international 

organizations, and the scientific 

community on tobacco science policy 

and tobacco science issues. 

12. Serves as the focal point for 

overall management of Center activities 

related to science priorities, resources, 

and leveraging efforts, as well as peer 

review of scientists and scientific 

programs. 

13. Advises the Commissioner, 

Deputy Commissioner, and other key 

officials on scientific facilities and 

participates with other agency 

components in planning such facilities. 

14. Administers the Tobacco Advisory 

Committee that advises the Center 

Director, Deputy Director, and other key 

officials regarding the quality and 

direction of tobacco science and 

scientific issues. 

II. Delegation of Authority. Pending 

further delegation, directives or orders 

by the Commissioner of the Food and 

Drugs, all delegations and redelegations 

of authority made to officials and 

employees of affected organizational 

components will continue in them or 

their successors pending further 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Development of Antiviral Products for 

Treatment of Smallpox and Related 

Poxvirus Infections; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public workshop regarding scientific 

issues in clinical development of 

antiviral drug products for treatment of 

smallpox and related poxvirus 

infections. This public workshop is 

intended to provide information for and 

gain perspective from health care 

providers, academia, and industry on 

various aspects of antiviral product 

development for smallpox and related 

poxvirus infections, including the status 

of clinical understanding of smallpox 

from pre-eradication experience, current 

epidemiology of naturally occurring 

poxvirus infections, potential effect of 

antiviral treatment for smallpox and 

related poxvirus infections, and issues 

pertaining to animal models for 

smallpox and related poxvirus 

infections. The input from this public 

workshop will help in developing topics 

for further discussion. 

Dates and Times: The public 

workshop will be held on September 1, 

2009, from 8:30 a.m. to 5:30 p.m. and on 

September 2, 2009, from 8 a.m. to 4 p.m. 

Location: The public workshop will 

be held at the Crowne Plaza Silver 

Spring, 8777 Georgia Ave., Silver 

Spring, MD 20910. 

Contact Person: Chris Moser or Lori 

Benner, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, Office of Antimicrobial 

Products, New Hampshire Ave., Bldg. 

22, rm. 6209, Silver Spring, MD 20993– 

0002, 301–796–1300. 

Registration: To register 

electronically, e-mail registration 

information (including name, title, firm 

name, address, telephone, and fax 

number) to 

SmallpoxWkshp@fda.hhs.gov by August 

24, 2009. Persons without access to the 

Internet can call 301–796–1300 to 

register. Registration is free for the 

public workshop, but interested parties 

are encouraged to register early because 

spaced is limited. Seating will be 

available on a first-come, first-served 

basis. Persons needing a sign language 

interpreter or other special 

accommodations should notify 

Christine Moser or Lori Benner (see 

Contact Person) at least 7 days in 

advance. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing a public workshop 

regarding antiviral drug development 

for smallpox and related poxvirus 

infections. This public workshop will 

focus on scientific considerations in the 

clinical development of products for 

treatment of smallpox and related 

poxvirus infections. This public 

workshop is intended to provide 

information regarding historical 

perspectives on smallpox and current 

perspectives on related poxvirus 

infections in humans. The workshop 

will explore approaches to assessing the 

potential effect of antiviral treatment for 

smallpox and related poxvirus 

infections. Issues pertaining to animal 

models for smallpox and related 

poxvirus infection and their 

relationship to disease in humans will 

be discussed at the workshop. In 

addition, the workshop will include 

perspectives of public health 

organizations on possible uses of an 

antiviral product for poxvirus 

infections. 

The agency encourages individuals, 

patient advocates, industry, consumer 

groups, health care professionals, 

researchers, and other interested 

persons to attend this public workshop. 

Transcripts: Transcripts of the public 

workshop may be requested in writing 

from the Freedom of Information Office 

(HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6–30, Rockville, MD 20857, 

approximately 20 working days after the 

public workshop, at a cost of 10 cents 

per page. Transcripts will also be 

available on the Internet at http:// 

www.fda.gov/Drugs/NewsEvents/ 

ucm169065.htm approximately 45 days 

after the workshop. 

Dated: August 11, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–19781 Filed 8–17–09; 8:45 am] 

BILLING CODE 4160–01–S 


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