[Federal Register Volume 72, Number 168 (Thursday, August 30, 2007)]
[Notices]
[Pages 50112-50114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-4259]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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

    Part D, Chapter D-B, (Food and Drug Administration), of 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, and 
in pertinent part at 57 FR 54239) is being amended to reflect the 
restructuring of the Office of the Commissioner (OC), Food and Drug 
Administration (FDA). This reorganization includes the establishment of 
four Deputy-level offices within the Office of the Commissioner, the 
changes are as follows:
    I. Under Part D, Food and Drug Administration, delete the Office of 
the Commissioner (DA) 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 (DA), Office of the Chief Counsel (DAA), 
Office of the Chief of Staff (DAB), Office of International and Special 
Programs (DAL), Office of Operations (DAM), Office of Policy, Planning 
and Preparedness (DAH), Office of Scientific and Medical Programs 
(DAE).
    DA.20 Functions
    A. Office of the Commissioner D(A)--The Office of the Commissioner 
(OC) includes the Commissioner and Deputy Commissioner who are 
responsible for the efficient and effective implementation of FDA 
mission.
    B. Office of the Chief Counsel (DAA)--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, 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 (HHS), and 
represents FDA in court proceedings and administrative hearings with 
respect to programs administered by FDA.
    2. Provides legal advice and policy guidance for programs 
administered by FDA.
    3. Acts as liaison to the Department of Justice and other Federal 
agencies for programs administered by FDA.
    4. Drafts or reviews all proposed and final regulations and Federal 
Register notices prepared by FDA.
    5. Performs legal research and gives legal opinions on regulatory 
issues, actions, and petitions submitted to FDA.
    6. Reviews proposed legislation affecting FDA that originates in 
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.
    C. Office of the Chief of Staff (DAB)--The Office of the Chief of 
Staff (OCOS):
    1. Advises and provides integrated policy analysis and strategic 
consultation to the Commissioner, Deputy Commissioners, Associate 
Commissioners, Center Directors and other 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 FDA.
    2. Provides leadership, coordination and management of the 
Commissioner's priority policies and issues across the Office of the 
Commissioner and FDA-wide. Identifies, triages, supervises and tracks 
related actions from start to finish in conjunction with senior 
leadership across FDA.
    3. Provides ddidrect support to the Commissioner of Food and Drugs 
and serves as major point of contact between the FDA Centers and 
Offices and the Commissioner.
    4. Serves as the principal liaison to HHS and coordinates and 
manages activities between FDA and HHS. Works with the FDA Centers and 
Offices to ensure assignments or commitments made related to these 
activities are carried out.
    5. Serves as one of the Commissioner's primary strategic liaisons 
with staff, partners, and the community at large.
    6. Manages budget and resources and provides operation oversight 
for the FDA's Office of Legislation, Office of the

[[Page 50113]]

Executive Secretariat, Office of Public Affairs, and Office of External 
Relations
    7. Provides top level leadership and guidance on issues and actions 
tied to the FDA's external communications, public affairs, and 
legislative matters.
    D. Office of International & Special Programs (DAL). The Office of 
International and Special Programs (OISP):
    1. Serves as FDA focal point for all international matters, 
pediatric matters, and combination product matters.
    2. Advises the Commissioner and other key FDA officials on FDA's 
formulation and execution and cross cutting and precedent setting 
issues involving international, pediatric, and combination product 
matters.
    3. Serves as the 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.
    4. Directs and monitors FDA strategic planning, priority-setting, 
and resource allocation processes for FDA international, pediatric and 
combination product matters.
    5. Provides leadership to FDA program areas for international, 
pediatric and combination product activities.
    6. Serves as the focal point for FDA international visitor program.
    7. Serves as the focal point for FDA and the authority for policies 
and procedures pertaining to international travel.
    8. Serves as the focal point for international-related training 
(external and internal).
    9. Serves as the focal point for FDA international technical 
cooperation and assistance activities.
    10. Serves as FDA focal point for all information exchange with 
foreign counterparts on international matters to ensure consistency 
internally and externally.
    11. Serves as FDA focal point for contacts with foreign governments 
and international organizations (including Washington, DC embassies).
    12. Serves as FDA focal point for planning and coordinating 
meetings involving international, pediatric and combination product 
matters.
    E. Office of Operations (DAM)--The office of Operations (00):
    1. Provides executive direction, leadership, coordination, and 
guidance for the overall day-to-day operations of FDA assuring the 
timely and effective implementation of operations and high quality 
delivery of services across FDA and its Centers.
    2. Oversees the day-to-day operational activities and the 
interaction and execution of new program initiatives across all 
Centers, Field offices, Regions, and the Office of the Commissioner.
    3. Advises and assists the Commissioner, Deputy Commissioners, 
Chief of Staff, Chief Counsel, Center Directors, and other key FDA 
officials on various management and business processes, compliance-
oriented and legislative matters of FDA.
    4. Works with other senior FDA leadership to make decisions that 
are consistent with broad conceptual guidelines of the Commissioner, to 
meet the changing needs of FDA and new legislation.
    5. Leads FDA effort to analyze agency business processes for 
process modernization and bioinformatics support.
    6. Leads and coordinates the Prescription Drug User Fee Act program 
initiative for Performance Management and quality systems studies.
    7. Coordinates FDA's business process planning function in support 
of business process improvement and automation efforts.
    8. Provides executive leadership and operational oversight to the 
Office of the Commissioner.
    9. Assure that the conduct of FDA administrative and financial 
management activities, including budget, finance, human resources, 
organization, methods, and similar support activities effectively 
support program operations.
    10. Provides FDA's administrative management services including 
information technology, communications, financial transaction 
functions, procurement, facilities, and equal employment opportunity 
and diversity management. Utilizes a call center to address all 
administrative and information technology management issues, and 
monitors and analyzes operational performance and customer 
satisfaction.
    11. 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 FDA's programs 
and financial plans.
    12. Provides leadership and direction regarding all aspects of a 
variety of FDA management programs including internal controls, OIG 
liaison, 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.
    13. Advises the Commissioner and other key Agency officials on 
administrative management and budget matters for components within the 
Office of the Commissioner (OC).
    14. Provides advice and guidance with regard to formulation and 
development of administrative management policies; procedures, and 
controls.
    15. Provides advice and assistance to the Commissioner and senior 
management officials in information technology resources and programs. 
Establishes and oversees implementation of the FDA information 
technology policy and governance, procedures and processes to bring the 
Agency in conformance with the Clinger/Cohen Act. Establishes, directs 
and leads FDA level programs and all strategic aspects of information 
technology including: information technology (IT) shared services, 
telecommunications, security, strategic planning, capital planning and 
investment control, and enterprise architecture.
    16. Plans, organizes, and carries out annual and multi-year 
budgeting in support of FDA's public health mission and programs. 
Provides staff assistance in justifying budgets through executive and 
congressional echelons. After appropriations, develops an orderly 
expenditure plan.
    17. Serves as the first responder for FDA in emergency and crisis 
situations involving FDA regulated products or in situations where FDA 
regulated products are needed to be utilized or deployed.
    F. Office of Policy, Planning and Preparedness (DAH)--The Office of 
Policy, Planning and Preparedness (OPPP):
    1. Advises the Commissioner and other key FDA officials on matters 
relating to policy, development of regulations and guidance, 
legislative issues, and planning and evaluation activities, and 
counter-terrorism and emerging threats.
    2. Participates with the Commissioner in the formulation of the 
basic policies and operational philosophy, which guide FDA in 
effectively implementing its responsibilities.
    3. Oversees and directs the FDA's rulemaking activities and 
regulations and guidance development system.
    4. Serves as FDA focal point for developing and maintaining 
communications, policies, and programs with regard to development.
    5. Oversees and directs FDA planning and evaluation activities, 
including the

[[Page 50114]]

development of programs and planning strategies through analysis and 
evaluation of issues affecting policies and program performance.
    G. Office of Scientific and Medical Programs (DAE). The Office of 
Scientific and Medical Program (OSMP):
    1. Serves as the focus for scientific medical and related 
activities in the Office of the Commissioner.
    2. Assists the Deputy Commissioner/Chief Medical Officer in 
planning, executing and monitoring FDA scientific and medical projects 
and programs.
    3. Operates the following FDA programs: a. Orphan Drug Program; b. 
Women's Health Program; c. Good Clinical Practices Program; d. Critical 
Path Initiative Program; and e. FDA Fellowship Program.
    4. Performs scientific research on the safety of regulated products 
through the National Center for Toxicological Research.
    5. Manages FDA's committee on Research Involving Human Subjects and 
FDA's Science Board.
    6. Represents the FDA on U.S. government committees and other 
Federal agencies on matters involving science or technology.
    7. Manages processes related to research coordination and 
scientific peer review activities at FDA.
    II. Delegations 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 23, 2007.
Michael O. Leavitt,
Secretary.
[FR Doc. 07-4259 Filed 8-29-07; 8:45 am]
BILLING CODE 4160-01-M