[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
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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
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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
