[Federal Register Volume 64, Number 128 (Tuesday, July 6, 1999)]
[Notices]
[Pages 36361-36368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-17019]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Statement of Organization, Functions, and Delegations of 
Authority

    The Food and Drug Administration (FDA) is being restructured to 
create a more streamlined and efficient Office of the Commissioner that 
will provide leadership without compromising programmatic 
effectiveness. More specifically, the goals of this reorganization are 
to: Create an Office of the Commissioner (OC) for which the principal 
focus is to provide leadership in building effective, two-way 
communication between the agency and all of our stakeholders, including 
patients, consumers, Congress, the Administration, the regulated 
industry, health care professionals, and other scientific advisors and 
between agency management and employees; enable FDA to implement agency 
priorities and to develop agency policy with primary input from the 
Center Directors and the Associate Commissioner for Regulatory Affairs, 
and with legal advice from the Chief Counsel; streamline the OC to make 
the overall agency more effective and efficient with roles and 
responsibilities clearly delineated; and retain in OC only those staff 
functions which cannot be reasonably and more effectively performed in 
the Centers or the Office of Regulatory Affairs (ORA).
    The new agency structure will consist of one Deputy Commissioner 
rather than the current four deputy structure. The Deputy Commissioner 
position will be established within the immediate OC. The Office of 
Operations will be abolished and the Center Directors and Associate 
Commissioner for Regulatory Affairs will report directly to the 
Commissioner. In addition, the Office of the Chief Counsel, Office of 
the Administrative Law Judge, and the Office of Equal Opportunity (OEO) 
(formerly titled the Office of Equal Employment and Civil Rights) will 
remain in OC. The OEO will assume the agency wide diversity program 
functions.
    A new position will be established in the OC titled the Senior 
Associate Commissioner. The incumbent will head a new Office of the 
Senior

[[Page 36362]]

Associate Commissioner (OSAC). This Office will be responsible for 
coordinating all activities within the OC as well as providing advisory 
committee oversight. This Office will include the Office of the 
Ombudsman, the Office of Executive Secretariat, the Office of Public 
Affairs (formerly in the Office of External Affairs (OEA)), the Office 
of Orphan Products Development (formerly in the Office of Operations 
(OO)), the Office of Internal Affairs, and the Office of Tobacco 
Programs (formerly in the Office of Policy (OP)).
    The former Office of Policy will be abolished. A new position will 
be established in the OC titled the Senior Associate Commissioner for 
Policy, Planning and Legislation. The new Office of Policy, Planning, 
and Legislation will be comprised of a new Policy office, the Office of 
Legislation (formerly titled the Office of Legislative Affairs in the 
OEA), and the Office of Planning (formerly titled the Office of 
Planning and Evaluation from the Office of Management and Systems), 
which will include the Management Initiatives Staff.
    The Office of External Affairs will be abolished. As a result of 
the growing importance of international policy and activities, a new 
Office of International and Constituent Relations will be established. 
The new Office of International and Constituent Relations will consist 
of a new Office of International Programs, the Office of Consumer 
Affairs, the Office of Women's Health and the Office of Special Health 
Issues, all formerly in the OEA.
    The current incumbent's position will be retitled Deputy 
Commissioner for International and Constituent Relations. This position 
will be converted to Senior Associate Commissioner when vacated.
    The Industry and Small Business Liaison Staff (formerly in the OEA) 
will be abolished and its staff reassigned; some of its meeting 
scheduling functions will be realigned to the Office of Public Affairs, 
OSAC. The Office of Health Affairs (formerly in the OEA) will be 
abolished. Some of its functions (health assessments, patent term 
restorations, and scheduling of controlled substances) will be 
realigned to the Center for Devices and Radiological Health. 
Responsibility for 21 CFR parts 16 and 12 hearings will be realigned to 
the Office of the Ombudsman, OSAC.
    The Office of Management and Systems will remain relatively 
unchanged in function except that many of the transactional functions 
of management will be decentralized to the Centers. The Divisions of 
Personnel Operations I, II, and III will be decentralized. The Centers 
and ORA will be functionally responsible for processing their personnel 
actions. The Office of Human Resources and Management Services will 
continue to process OC personnel actions. As noted earlier, the Office 
of Planning and Evaluation will be realigned to the Office of Policy, 
Planning, and Legislation.
    The position title Deputy Commissioner for Management and Systems 
will be retained until this position is vacated. At such time the 
position will be converted to Senior Associate Commissioner for 
Management and Systems.
     Part D, Chapter DA, Office of the Commissioner, FDA, 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, and in pertinent part at (56 
FR 29484, June 27, 1991)) is amended to reflect the restructuring of 
FDA as follows:
    Office of the Commissioner (DA): The Commissioner and Deputy 
Commissioner are responsible for the efficient and effective 
implementation of the FDA mission.
    Office of the Chief Counsel (DAA): Subject to the professional 
supervision and control of the General Counsel, represents FDA in court 
proceedings and administrative hearings with respect to programs 
administered by FDA.
    Provides legal advice and policy guidance for programs administered 
by FDA.
    Acts as liaison to the Department of Justice and other Federal 
departments for programs administered by FDA.
    Drafts or reviews all proposed and final regulations and Federal 
Register notices prepared by FDA.
    Performs legal research and gives legal opinions on regulatory 
issues, actions, and petitions submitted to FDA.
    Reviews proposed legislation affecting FDA that originates in the 
Department or on which Congress requests the views of the Department.
    Provides legal advice and assistance to the Office of the Secretary 
on matters within the expertise of the Chief Counsel.
    Office of Equal Opportunity (DAC): Advises and assists the 
Commissioner and other key agency officials on Equal Employment 
Opportunity (EEO) and Civil Rights activities which impact on policy 
development and execution of program goals.
    Serves as the agency focal point and liaison with the Department, 
and other Federal agencies, State, and local governments, and other 
organizations regarding EEO and Civil Rights matters.
    Develops and recommends policies and priorities designed to 
implement the intent of the Office of Personnel Management, Equal 
Employment Opportunity Commission, Office of Civil Rights, Department 
of Health and Human Services requirements under Executive Orders, 
regulations, EEO and Civil Rights legislation.
    Provides leadership, direction, and technical guidance to the 
agency on EEO and Civil Rights matters.
    Develops plans, programs, and procedures designed to ensure the 
prompt adjudication of complaints of alleged discrimination based on 
race, color, sex, age, religion, national origin, handicap, and sexual 
orientation.
    Develops and oversees agency diversity initiatives and the 
diversity databank.
    Provides alternative dispute resolution and mediation services as 
needed.
    Develops and maintains training and technical assistance programs 
for agency EEO managers, counselors, special emphasis/program 
representatives, employees, supervisory personnel, and other key agency 
officials.
    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's representatives, 
and such other assistance as may be needed for EEO activities.
    Develops, implements, and monitors the agency's Affirmative Action 
Plan and directs the agency's Affirmative Employment Program to achieve 
specific objectives.
    Issues policies, publications and information dissemination 
services to agency employees including Commissioner Policy Statements, 
brochures, the EEO Counselors Manual, etc.
    Develops labor-management partnerships on EEO matters.
    Provides sign language interpreting services and manages the 
interpreting services contracts.
    Office of the Administrative Law Judge (DAD): Schedules and 
conducts formal evidentiary public hearings under 21 CFR part 12, under 
the Federal

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Food, Drug, and Cosmetic Act, as amended, as well as other related laws 
and the Administrative Procedure Act (5 U.S.C. 511 et seq.).
    Issues Initial Decisions containing findings of fact and 
conclusions of law based on the independent review and evaluation of 
all evidence of record in formal hearings.
    Office of the Senior Associate Commissioner (DAF): Advises the 
Commissioner and other key agency officials on agency-level activities 
and issues that affect agency wide programs, projects, strategies, and 
initiatives.
    Coordinates activities involving emergency or crises situations and 
resolves complex problems and issues related to agency programs that 
are sensitive and controversial that impact upon agency relations with 
other Federal agencies and foreign governments.
    Oversees and directs the agency's ombudsman, public affairs, 
tobacco program, orphan products, executive secretariat, and advisory 
committee functions to ensure coherence in decisionmaking and the 
efficient operation of these functions internally and across agency 
jurisdictions.
    Provides leadership and direction to assure the efficient and 
effective planning, performance, and evaluation of oversight 
activities.
    Office of Executive Secretariat (DAFA): Coordinates identification 
of and expedites development and implementation of the agency's highest 
program priorities and initiatives for the Commissioner.
    Develops and maintains management information necessary for 
monitoring the Commissioner's and agency's goals and priorities.
    Advises the Commissioner and other key agency officials on all 
activities that affect agency wide programs, projects, and initiatives. 
Informs appropriate agency staff of the decisions and assignments made 
by the Commissioner and other key agency officials.
    Ensures that materials in support of recommendations presented for 
the Commissioner's consideration are comprehensive, accurate, fully 
discussed, and encompass the issues involved.
    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.
    Provides direct support to the Commissioner and other key agency 
officials, including briefing materials, background information for 
meetings, responses to outside inquiries, and maintenance and control 
of the Commissioner's working files.
    Performs agency wide assignments involving complex problems and 
issues related to agency programs, strategies and activities, including 
preparation of special reports for the Department.
    Coordinates the agency's communications with the Public Health 
Service (PHS), DHHS, and the White House including correspondence for 
the Assistant Secretary for Health and Secretarial signatures.
    Office of Public Affairs (DAFB): Advises and assists the 
Commissioner and other key agency officials on all public information 
programs; acts as the focal point for disseminating news on FDA 
activities and as a liaison with PHS and the Department on public 
information programs.
    Plans, develops, implements, and monitors policy and programs on 
agency media relations and consumer information and education programs 
conducted through the media, FDA's consumer affairs officers, and other 
communications sources.
    Plans, develops, produces, and publishes agency publications and 
graphic arts materials.
    Coordinates agency implementation of the Freedom of Information 
(FOI) Act and the Privacy Act.
    Processes requests for information under FOI.
    Executes FOI denial authority for the agency.
    Press Relations Staff (DAFB-1): Advises and assists top level 
agency officials on print press matters involving mass media 
communications.
    Plans, develops, and implements agency wide print media strategies 
for disseminating regulatory and educational material to the public 
through the mass media.
    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.
    Establishes policy for and coordinates all print media information 
activities, including news interviews and responses to inquiries; 
prepares position and policy statements for use by agency employees in 
responding to print media questions; tracks issues of potential 
interest to the media.
    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 and maintains mailing lists for these documents.
    Compiles, publishes, and distributes the weekly FDA Enforcement 
Report and the FDA Public Calendar; maintains the FDA Daily Clipping 
Service and FDA's electronic bulletin board; and coordinates the Daily 
Media Report.
    Communications Staff (DAFB-2): Identifies consumer communication 
and educational requirements for the agency and creates, implements, 
and coordinates appropriate programs conducted through the media, 
agency consumer affairs officers, and other communication sources.
    Plans, designs, produces, publishes, and disseminates audiovisual 
materials, exhibits, posters, publications, and periodicals, including 
FDA Consumer, FDA Today, and the FDA Drug Bulletin; participates in the 
planning and development of all publications and audiovisual aspects of 
communications programs directed at mass audiences.
    Provides centralized agency graphic arts and editorial services for 
public information materials.
    Acts as the 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, Office of 
Management and Budget (OMB), and the White House.
    Provides agency wide advice and consultation in the production of 
audiovisual materials; maintains centralized files of photographs and 
audiovisual materials for use by all agency components.
    Freedom of Information Staff (DAFB-3): Establishes agency wide 
policy and provides overall direction and leadership for the Freedom of 
Information (FOI) program and Privacy Act program.
    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 Freedom of Information 
Act, the Privacy Act, FDA regulations, and other relevant statutes.
    Receives, reviews, controls, coordinates, and routes all FOI 
requests to the proper action office; designs and implements control 
mechanisms to

[[Page 36364]]

ensure that FOI and Privacy Act inquiries are processed and responded 
to within established timeframes.
    Reviews all recommendations for denials submitted by Headquarters 
and field FOI Officers. Determines the need for supplemental 
information and/or changes in the denial recommendation and coordinates 
required action with the submitting office.
    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.
    Maintains copies of agency manuals, indexes, and other records 
required to be on public display.
    Operations Staff (DAFB-4): Directs the effective utilization of all 
management resources by coordinating the management, facilities, 
budget, and equipment resources for the Office of Public Affairs.
    Reviews organizational, management, and administrative policies of 
the Office to appraise the efficiency and effectiveness of operations.
    Identifies potential management problems and/or needs and plans, 
develops, and conducts management studies.
    Broadcast Media Staff (DAFB-5): Advises and assists top level 
agency officials on electronic media matters involving mass media 
communications.
    Plans, develops, and implements agency wide broadcast media 
strategies for disseminating regulatory and educational materials to 
the public through the mass media.
    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.
    Establishes policy for and coordinates all broadcast media 
information activities, including on-camera interviews and response 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.
    Plans and coordinates all broadcast media training for the agency.
    Office of the Ombudsman (DAFC): Serves as the agency lead on issues 
involving the administrative processing of product applications for FDA 
regulated products.
    Provides advice and guidance to the Commissioner and other key 
agency officials regarding premarket approval processes for all FDA 
regulated products including requirements pertaining to applications, 
petitions, amendments, and supplements; and product, processing, 
packaging, and emerging product technologies.
    Investigates and resolves internally and externally generated 
complaints and disagreements regarding 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.
    Represents the Commissioner or other key agency officials and 
serves as the agency's principal authority and spokesperson to top 
level agency and departmental officials, regulated industry 
representatives, scientific and professional organizations and groups, 
and other professional, and consumer associations concerning critical 
and significant issues and activities related to FDA regulated 
products.
    Office of Orphan Products Development (DAFD): 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.
    Develops and communicates agency policy and makes decisions on 
approval of sponsor requests and incentives, under the Federal Food, 
Drug, and Cosmetic Act (the act), including orphan drug protocol 
assistance under section 525 of the act (21 U.S.C. 360aa), orphan drug 
designation under section 526 (21 U.S.C.360bb), orphan drug exclusivity 
under section 527 (21 U.S.C.360cc), and orphan drug grants and 
contracts to support clinical research and other areas of agency policy 
related to the development of products for rare disorders.
    Represents the Commissioner or serves as the agency's principal 
authority and spokesperson to the PHS Orphan Products Board, other 
governmental committees, industry, professional and consumer 
associations, requesting agency participation in orphan product 
development activities.
    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.
    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 Tobacco Programs (DAFE): Serves as the FDA focal point to 
provide programmatic direction to agency personnel on tobacco matters 
related to compliance, outreach activities, and product review under 
the Federal Food, Drug, and Cosmetic Act as amended.
    Provides advice, guidance, oversight, and coordination to a variety 
of substantive activities in response to the FDA's rule to regulate the 
sale and distribution of cigarettes and smokeless tobacco products.
    Establishes and maintains partnerships with Congress, other Federal 
agencies (e.g., Center for Disease Control and Prevention, Substance 
Abuse and Mental Health Services Agency, and the National Institutes of 
Health, etc.), State and local authorities, consumer groups, industry, 
and other key stakeholders on matters related to cigarettes and 
smokeless tobacco products.
    Designs and implements a regulatory program that specifically 
addresses cigarettes and smokeless tobacco products.
    Provides oversight and coordination for compliance, surveillance, 
and education programs and develops and disseminates pertinent 
information related to the FDA's rule to regulate the sale and 
distribution of cigarettes and smokeless tobacco products.
    Provides agency guidance and coordinates technical evaluation of 
complex, precedent setting regulatory and scientific issues for 
existing, new, and/or novel tobacco products.
    Identifies, plans, and develops policies, strategies, guidelines, 
programs, research protocols, standards, and educational materials, in 
cooperation with appropriate agency personnel.
    Develops and utilizes methods to evaluate the effectiveness of 
program operations.
    Develops and implements guidelines to ensure advertising, 
marketing, and youth access restrictions.
    Office of Internal Affairs (DAFF): Provides a centralized agency 
wide investigative resource for the Commissioner and top agency 
management.
    Provides a centralized investigative liaison between FDA and the 
Office of the Inspector General (OIG).
    Serves as a FDA investigative resource to conduct internal FDA 
investigations and to support OIG investigations.

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    Conducts special assignments relative to the functions of this 
Office as requested.
    Office of International and Constituent Relations (DAG): Serves as 
the agency focal point for developing and maintaining international 
communications and programs.
    Advises and assists the Commissioner on health issues that have an 
impact on policy, direction, and long-range program goals.
    Advises and assists the Commissioner on consumer affairs issues. 
Serves as the agency focal point for coordinating information from the 
appropriate agency components about significant consumer affairs 
issues.
    Office of International Programs (DAGA): Serves as the agency focal 
point for international matters.
    Advises the Commissioner and other key agency officials on agency 
formulation and execution and cross cutting and precedent setting 
issues involving international matters.
    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.
    Directs and monitors agency strategic planning, priority-setting, 
and resource allocation processes for agency international matters.
    Provides support to agency program areas for international 
activities.
    Serves as the focal point for the agency international visitor 
program.
    Provides support and issues guidelines for the visiting scientist 
program.
    Serves as the focal point for the agency international travel 
program.
    Serves as the focal point for international-related training 
(external and internal).
    Serves as the focal point for agency technical cooperation and 
assistance activities.
    Serves as the agency focal point for information exchange on 
international matters to ensure consistency internally and externally.
    Provides a focal point for contacts with foreign governments and 
international organizations (including Washington, DC embassies).
    Serves as the agency focal point for planning and coordinating 
meetings involving international matters.
    Office of Consumer Affairs (DAGB): Serves as the agency focal point 
for coordinating information from the Centers, the Office of Regulatory 
Affairs, and other agency components about significant or public 
interest issues; develops mechanisms to gather consumer views for use 
in developing agency policy on these issues; monitors the development 
of agency policy on these issues; apprises the Commissioner and other 
key agency officials on the impact of consumer involvement in resolving 
these issues.
    Serves as the agency focal point for contacting and involving 
national consumer groups on agency public participation programs; 
analyzes consumer feedback at the national level to assess potential 
major health issues, to determine national trends in consumer concerns, 
and to compile a consumer perspective of agency regulatory policies and 
activities; informs other agency components of consumer trends.
    Serves as the agency focal point for coordinating information from 
Centers, the Office of Regulatory Affairs, and other agency components 
about potential public participation opportunities and informs the 
consumer of these activities.
    Designs and administers special community outreach projects to 
broaden agency interaction with special target audiences, including the 
economically and educationally disadvantaged and the minorities.
    Administers consumer awareness and advocacy skills training 
programs designed to educate lay consumers and current/potential 
consumer representatives for advisory committees to enhance their 
participation in agency regulatory and decisionmaking processes.
    Administers the agency selection process for consumer 
representatives on advisory committees and panels.
    Office of Women's Health (DAGC): Serves as the principal advisor to 
the Commissioner and other key agency officials on scientific, ethical, 
and policy issues relating to women's health.
    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.
    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.
    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.
    Serves as the agency's liaison with other agencies, industry, and 
professional associations with regard to the health of women.
    Office of Special Health Issues (DAGD): Serves as an information 
resource to FDA and provides advice to the Commissioner and other key 
agency officials on matters related to the acquired immune deficiency 
syndrome (AIDS), cancer, Alzheimer's Disease, and other special health 
issues.
    Coordinates interactions between FDA and consumer and professional 
groups dealing with AIDS, cancer, Alzheimer's Disease, and other 
special health issues.
    Serves as a liaison point to coordinate contacts between FDA and 
other Federal agencies to ensure effective coordination and 
communication on AIDS, cancer, Alzheimer's Disease, and other special 
health issues.
    Provides internal coordination on FDA activities related to AIDS, 
cancer, Alzheimer's Disease, and other special health issues.
    Assists in the planning, administration, development, and 
evaluation of FDA policies related to AIDS, cancer, Alzheimer's 
Disease, and other special health issues.
    Office of Policy, Planning, and Legislation (DAH): Advises the 
Commissioner and other key agency officials on matters relating to 
agency policy, regulations development, legislative issues, and 
planning and evaluation activities.
    Participates with the Commissioner in the formulation of the basic 
policies and operational philosophy, which guide the Agency in 
effectively implementing its responsibilities.
    Oversees and directs the agency's legislative activities, including 
legislative needs, pending legislation, and oversight activities.
    Oversees and directs the agency's rulemaking activities and 
regulations development system.
    Serves as the agency focal point for developing and maintaining 
communications, policies, and programs with regard to regulations 
development.
    Oversees and directs FDA's planning and evaluation activities, 
including the development of programs and planning strategies through 
analysis and evaluation of issues affecting policies and program 
performance.
    Office of Policy (DAHA): Advises and assists the Commissioner, the 
Senior Associate Commissioner for Policy, Planning and Legislation and 
other key agency officials on matters relating to agency policy and 
regulations development.

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    Serves as the agency focal point for developing broad agency 
policy.
    Oversees, directs, and coordinates the agency's rulemaking 
activities and regulations development system.
    Serves as the agency focal point for developing and maintaining 
communications, policies, and programs with regard to regulations 
development.
    Initiates new and more efficient systems and procedures to 
accomplish agency goals in the rulemaking process.
    Regulations Policy and Management Staff (DAHA-1): Serves as the 
agency focal point for developing and maintaining communications, 
policies, and programs with regard to regulations development. Directs, 
manages, and coordinates the agency's rulemaking activities and 
regulations development system. Initiates new and more efficient 
systems or procedures to accomplish agency goals in the rulemaking 
process.
    Serves as the agency's focal point with the Department of Health 
and Human Services, Office of Managament and Budget, and other Federal 
agencies for policies and programs concerning regulations development.
    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 General 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.
    Ensures that all regulations required by statute are issued.
    Coordinates, with other agency components, the evaluation of 
existing regulations to determine whether they are efficiently and/or 
effectively accomplishing their intended purpose. Identifies 
regulations that require revision to correspond with current standards 
and those that should be revoked due to obsolescence. Makes 
recommendations for disposition of these regulations.
    Arbitrates regulatory policy disagreements between agency 
components during the preparation of Federal Register documents.
    Regulations Editorial Section (DAHA-11): FDA's official liaison 
with 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.
    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 CFR materials). Controls numbering and organization of agency 
codified material to insure proper structure of regulations being 
issued.
    Policy Development and Coordination Staff (DAHA-2): Advises and 
assists the Senior Associate Commissioner for Policy, Planning, and 
Legislation concerning information that may affect current or proposed 
FDA policies.
    Advises the Senior Associate Commissioner for Policy, Planning, and 
Legislation and other key agency officials on the formulation of broad 
agency regulatory policy.
    Establishes procedures for agency policy formulation and monitors 
policy formulation activities throughout the agency.
    Negotiates the resolution of policy issues involving more than one 
component of the agency.
    Develops and coordinates the review and analysis of policy.
    Initiates and participates in interagency discussions on agency 
regulations, plans, and policies to improve coordination of Federal 
regulations. When appropriate, assumes the lead in working with other 
Federal, State, or local agencies on a specific regulation or in 
developing an effective alternative regulatory approach.
    Serves on agency task forces that are critical elements in the 
initiation, study, and resolution of priority policy issues.
    Serves as the agency liaison for intergovernmental policy 
development.
    Office of Planning (DAHB): Advises and assists the Commissioner and 
other key agency officials concerning the performance of the FDA 
planning and evaluation activities.
    Develops program and planning strategy through analysis and 
evaluation of issues affecting policies and program performance.
    Develops, installs, and monitors the agency wide planning system 
including the 5-year plan, strategic plan, and functional plans.
    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.
    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.
    Develops FDA evaluation programs and systems to evaluate overall 
FDA program accomplishments against objectives and priorities, 
recommending changes as necessary.
    Evaluates impact of FDA programs on consumer protection.
    Manages the operation of the agency wide Evaluation Review Board.
    Coordinates the evaluation reviews of FDA by external groups.
    Planning Staff (DAHB-1): Directs the agency long-range planning 
processes, including strategic and program planning, and coordinates 
with the Department of Health and Human Services (DHHS) long-range 
planning process.
    Prepares the FDA Forward Plan and Annual Report.
    Assists and consults with agency components in their planning.
    Analyzes base line data and determines importance of external 
factors, including consumer safety and regulatory expectations, which 
affect the agency.
    Consults with and supports the Office of Management and Systems in 
preparation of the agency budget; consults with and supports the Office 
of Legislation in the preparation of legislative proposals.
    Conducts special planning-related studies and critiques as 
requested.
    Coordinates the agency functional (regulatory, research, etc.) 
planning processes and supports agency staff units in planning, design, 
preparation, coordination, and execution.
    Represents the agency in departmental planning activities.
    Conducts analysis of resource requests submitted by agency 
components in order to develop resource recommendations for the 
Commissioner, to support the planning process, and to fulfill DHHS 
requirements.
    Designs and operates management communications systems.
    Coordinates and presents an annual regulatory development plan.
    Conducts the agency manpower management system.
    Evaluation Staff (DAHB-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.
    Performs analyses of significantly broad agency issues identified 
in the planning process. Recommends and/or

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implements steps to resolve these issues.
    Ensures that appropriate program evaluation activities are taken in 
agency components. Monitors and coordinates these efforts to assure 
uniqueness and a contribution to agency program goals.
    Develops the annual evaluation plan for the agency and coordinates 
with DHHS.
    Conducts special evaluation, analytical, and economic-related 
studies in support of agency policy development and in resolution of 
broad agency problems.
    Evaluates impact of external factors on agency programs, including 
consumer expectations and prospective legislation.
    Evaluates the impact of agency operations and policies on regulated 
industries and other agency constituents.
    Evaluates Program Management System (PMS) projects to provide a 
basis for agency decisionmaking. Recommends PMS project selections for 
evaluation, conducts the evaluations, and provides written and/or oral 
reports to the Commissioner and/or program managers.
    Approves survey methodology, design, and questionnaires within the 
agency prior to Office of Management and Budget (OMB) clearance under 
the Paperwork Reduction Act; reviews Memoranda of Need, which require 
the collection of health research data and advises agency components on 
the planning and design of health research studies.
    Advises international health organizations (e.g., World Health 
Organization) on the use of program evaluation to strengthen program 
operations in member countries.
    Economics Staff (DAHB-3): Provides economic analyses as input to 
and support for decisions regarding agency policy issues.
    Serves as the agency focal point for economic analysis assistance 
and consultation; provides economic analysis assistance to agency 
components for regulatory and other program functions.
    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.
    Provides a resource of economic research material for use by agency 
officials in preparing testimony before congressional committees and in 
developing replies to inquiries directed to the agency.
    Conducts economic studies of FDA-related industries as a basis for 
forecasting trends, needs, and major problems affecting the agency.
    Provides agency representation to Congress, OMB, DHHS, and others, 
as appropriate, on economic issues relating to agency regulations and 
other current and proposed actions.
    Management Initiatives Staff (DAHB-4): Provides process expertise 
to agency components in designing consensus sessions with internal and 
external stakeholders.
    Assists and consults with agency components on the design and 
execution of key program and process reinventions.
    Assists and consults with agency scientific review components to 
enhance transparency, consistency, accountability, and continuous 
improvement of review processes.
    Facilitates cross organizational sharing of key program and process 
improvements.
    Serves as agency focal point on project management.
    Maintains an agency team of interactive management practitioners.
    Maintains and manages a facility for interactive management 
sessions for group problem-solving, action planning, consensus 
building, and redesign.
    Office of Legislation (DAHC): Advises and assists the Commissioner 
and other key agency officials concerning legislative needs, pending 
legislation, and oversight activities that affect FDA.
    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.
    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.
    Congressional Affairs Staff I (DAHC-1): Serves as the agency focal 
point with Congress, the Department, PHS, and other agencies on all 
congressional and legislative issues and activities as they pertain to 
the Center for Food Safety and Applied Nutrition, the Center for 
Veterinary Medicine, the National Center for Toxicological Research, 
and cross cutting agency organizational components and issues.
    Coordinates and prepares agency responses to congressional and 
legislative inquiries and other sensitive correspondence on various 
issues that affect the agency including proposed legislation, 
oversight, investigative, and constituent matters.
    Initiates, coordinates, and provides indepth analyses of agency 
legislative needs and proposed and pending legislation by preparing 
supporting documents, legislative proposals, and position papers for 
the Commissioner, other agency officials, Congress, and OMB.
    Develops and coordinates testimony for the agency and the 
Department for presentation to congressional committees; monitors 
hearings; and edits transcripts of agency testimony.
    Provides information on the agency's legislative programs and 
proposals to consumers and regulated industry.
    In collaboration with other FDA and Department offices, initiates 
and conducts appraisals of regulatory and scientific policies to 
resolve problems pertaining to FDA programs and policies under existing 
statutes.
    Congressional Affairs Staff II (DAHC-2): Serves as the agency focal 
point with Congress, the Department, PHS, and other agencies on all 
congressional and legislative issues and activities as they pertain to 
the Center for Biologics Evaluation and Research, the Center for Drug 
Evaluation and Research, and the Center for Devices and Radiological 
Health.
    Coordinates and prepares agency responses to congressional and 
legislative inquiries and other sensitive correspondence on various 
issues that affect the agency including proposed legislation, 
oversight, investigative, and constituent matters.
    Initiates, coordinates, and provides indepth analyses of agency 
legislative needs and proposed and pending legislation by preparing 
supporting documents, legislative proposals, and position papers for 
the Commissioner, other agency officials, Congress, and OMB.
    Develops and coordinates testimony for the agency and the 
Department for presentation to congressional committees; monitors 
hearings; and edits transcripts of agency testimony.
    Provides information on the agency's legislative programs and 
proposals to consumers and regulated industry.
    In collaboration with other FDA and Department offices, initiates 
and conducts appraisals of regulatory and scientific policies to 
resolve problems pertaining to FDA programs and policies under existing 
statutes.
    Congressional Affairs Support Staff (DAHC-3): Receives, assigns, 
and tracks all congressional correspondence, reviews written responses 
for grammar, accuracy, completeness, and general

[[Page 36368]]

quality and maintains congressional correspondence files.
    Prepares briefing books for congressional hearings, assists in the 
preparation and finalization of testimony, researches information in 
response to congressional, department and interagency requests (verbal 
or written), responds to incoming calls from Congress (subject to 
knowledge of program area), and provides office automation support.
    Office of Management and Systems (DAJ): Advises and assists the 
Commissioner and other key agency officials on various management and 
systems activities.
    Ensures that the conduct of agency administrative and financial 
management activities, including budget, finance, personnel, 
organization, methods, grants and contracts, procurement and property, 
records, and similar support activities, effectively support program 
operations.
    Coordinates the integration and development of management 
information systems.
    Advises the Commissioner on management information systems 
policies.
    Executive Management Staff (DAJ-1): Advises the Commissioner and 
other key agency officials in regard to administrative management 
matters for their components.
    Provides a focal point for administrative activities for the Office 
of the Commissioner.
    Develops, coordinates, and facilitates various administrative 
processes such as personnel, procurement, training, travel, and other 
pertinent areas as necessary.
    Establishes and maintains liaison with administrative officers 
throughout the serviced components to keep abreast with current issues.
    Prior Delegations of Authority. Pending further delegations, 
directives, or orders by the Commissioner of Food and Drugs, all 
delegations or redelegations of authority to positions of the affected 
organizations in effect prior to this date shall continue in effect in 
them or their successors.

    Dated: June 28, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-17019 Filed 6-30-99; 12:55 pm]
BILLING CODE 4160-01-F