[Federal Register Volume 75, Number 240 (Wednesday, December 15, 2010)]
[Notices]
[Pages 78259-78262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31383]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0618]
Statement of Organization, Functions and Delegations of Authority
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) has reorganized its
Center for Tobacco Products (CTP) by establishing two new offices:
Office of Health Communication and Education and the Office of
Compliance and Enforcement. In addition, CTP has made improvements to
the current offices' functional statements. This organizational change
is intended to fill the gaps in the current CTP structure and clarify
major responsibilities designed for long-term success in administering
the Family Smoking Prevention and Tobacco Control Act.
[[Page 78260]]
FOR FURTHER INFORMATION CONTACT: Erik Mettler, Office of Management; or
Sharon Chartos, Office of Management, Center for Tobacco Products, Food
and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850,
301-796-9200.
I. Introduction
The Statement of Organization, Functions and Delegations of
Authority for the Center for Tobacco Products (74 FR 41713, August 18,
2009) is amended to reflect the restructuring of the Center for Tobacco
Products that was approved by the Secretary of Health and Human
Services on November 15, 2010:
II. Organization
The Center for Tobacco Products is headed by the Director and
includes the following organizational units:
Center For Tobacco Products (DI)
1. Oversees the implementation of the Family Smoking Prevention and
Tobacco Control Act, which provides FDA with several new authorities.
These include restricting the marketing of tobacco products to minors;
requiring new warning labels for cigarettes and smokeless tobacco
products; prohibiting marketing measures that are misleading to
consumers; establishing tobacco product standards; requiring Good
Manufacturing Practice standards for tobacco product manufacturing
facilities; requiring industry reporting of tobacco product ingredient
and constituent data, including a description of the nicotine content
and delivery mechanisms; educating the public and regulated industry
about various provisions of the Family Smoking Prevention and Tobacco
Control Act; and enforcement authorities including but not limited to
enabling FDA to act quickly and effectively to remove products that are
in violation of the statute.
2. Provides programmatic and policy direction to appropriate Center
and Agency personnel on all matters related to implementation of the
Family Smoking Prevention and Tobacco Control Act and identifies
critical public health issues relating to tobacco product use.
3. Establishes and maintains effective relationships with senior
FDA, Department of Health and Human Services (HHS), and Administration
officials, industry representatives, Members of Congress, counterparts
from State, local, territorial, and tribal governments, representatives
from academia and public health organizations, and other key
stakeholders on matters related to tobacco products.
Office of the Center Director (DIA)
1. Provides vision, leadership, and strategic direction for all
Center activities related to regulation of tobacco products and
implementation of the Family Smoking Prevention and Tobacco Control
Act.
2. Provides vision, leadership, and strategic direction for all
Center activities related to protecting the public health and
communicating about the negative consequences of tobacco product use.
3. Plans, administers, coordinates, evaluates, and implements
overall Center scientific, legal, policy, regulatory, compliance,
public education, and management programs, policies, and plans.
4. Provides leadership and direction for Center management,
planning, and evaluation systems to ensure optimum utilization of
personnel, budgetary and financial resources, information technology,
professional development, and facilities.
5. Establishes a program to maintain the highest levels of
scientific quality and integrity for the Center.
6. Serves as the primary liaison and spokesperson on tobacco
products regulation and the public health consequences of tobacco
products use with FDA, HHS, Office of Management and Budget (OMB), the
White House, Congress and the media, as well as with a variety of
stakeholders, including regulated industry; tobacco control advocacy
organizations; scientific, public health, and medical associations;
academia; and State, local, territorial, and tribal governments.
7. Provides Center-wide program and strategic planning, execution,
and support to Center leadership; coordination, development, clearance,
and delivery of all Congressionally mandated reports, studies, and
analyses; and also high quality briefing materials, background
information for meetings, and speeches.
8. Provides correspondence control for the Center and controls and
processes all public correspondence. Develops and operates executive
correspondence tracking systems.
9. Manages the Center's Freedom of Information Act activities,
coordinating responses with other Center technical, legal, regulatory,
and policy units as well as developing direct responses.
10. Manages the Center's Ombudsman program.
11. Manages the Center's history program and archives.
Office of Management (DIB)
1. Provides authoritative advice and guidance to the Center
Director on management policies, guidelines, issues and concerns that
impact Center programs and initiatives.
2. Provides leadership, guidance, and direction regarding the
development of long-range strategic management plans, operational
plans, and systems for Center activities. Directs technical support
staff in providing essential management services and other critical
support functions.
3. Provides leadership and guidance as primary liaison with the FDA
Office of Management to ensure provision of a broad range of essential
technical support services.
4. Provides leadership and effective coordination as the primary
Center liaison and expert with the Office of Information Management for
provision and continuous improvement of information technology services
to include networking, scientific computing software engineering,
systems, and telecommunications.
5. Designs and develops performance management systems and
operational/business process plans.
6. Analyzes management performance trends, FDA cost structure, and
use of program resources.
7. Directs a variety of short-range and long-range special projects
or assignments of substantial significance to the Center.
8. Administers and executes the Center management and fiscal
planning and performance activities, budget formulation and execution,
payroll, accounting, and property management functions.
9. Analyzes, formulates, and develops the annual budget for the
Center in accordance with FDA, HHS, OMB, and Congressional guidelines.
Provides oversight and ensures compliance with all regulations
governing financial processes as outlined in FDA, HHS, OMB, and U.S.
Government Accountability Office policies. Manages FDA, HHS, OMB, and
Congressional inquiries regarding budget formulation and execution and
required quarterly reports to Congressional Appropriations Committees.
10. Develops, maintains, monitors, analyzes, and reports data to
Center management and program officials on the Center's budget/planning
resource monitoring and evaluations systems.
11. Provides leadership within the Center to ensure compliance with
statutes, executive orders, and administrative directives, such as the
Chief Financial Officer Act and the
[[Page 78261]]
Federal Financial Managers' Financial Integrity Act.
12. Serves as the liaison between the CTP and the Bethesda Field
Office, Atlanta Field Office, and/or Office of Management Programs on
all personnel issues including, but not limited to, Human Capital
Resources, appointment mechanisms, recruitment flexibilities, Senior
Executive Service (SES) appointments, Title 42 appointments, retention
flexibilities, and position management. Manages the Center's
Performance Management program and the Center's Awards program.
13. Manages, tracks, and maintains the Center's regulatory
submissions in accordance with FDA's records retention policies.
14. Receives, tracks, and stores all of Center's regulatory
submissions.
15. Manages, conducts, and analyzes studies designed to improve
Center processes and resource utilization and support requirements.
16. Manages facility-related activities for the Center including
leases, space needs, maintenance, and development of architectural
plans for move to FDA's White Oak campus.
17. Manages the Center's employee training and development
activities, including individual employee development plans. Manages
the Center's regulatory science fellowship program and other academic-
based fellowship programs.
Office of Policy (DIC)
1. Advises the Center Director and other key Agency officials on
public health, scientific, and regulatory policy development at the
Center.
2. Develops and evaluates Center-wide priorities and policies,
assuring FDA's statutory public health goals and policy needs are
integrated into initiatives across science, regulations, compliance,
public education, and management programs across the Center.
3. Ensures that Center policy decisions are consensus-based and
informed, when relevant and appropriate, through communications with
stakeholders in CTP, FDA, the Centers for Disease Control and
Prevention, National Institutes for Health, HHS, and other government
and relevant stakeholders and private agencies.
4. Monitors, coordinates, and advises the Center Director on policy
involving sensitive, controversial, and complex issues related to
Center activities that may involve precedent-setting matters or issues
of particular concern to the Center Director or FDA Commissioner of
Food and Drugs.
5. Analyzes and evaluates the impact and effectiveness of the
Center's overall impact on public health.
6. Oversees public health policy and analytics; coordinates and
conducts contingency analyses; manages special projects that require
quick reaction/problem solving and planning; and develops and oversees
the Center's approach to evolving issues in tobacco product regulation
and control, such as impact on population health, development of policy
aspects of tobacco product standards, modified risk products,
substantial equivalence, and marketing and advertising.
7. Provides economic and modeling analyses on policy options as
required.
8. Provides authoritative policy advice, guidance, assistance,
interpretations, and recommendations to CTP, FDA, HHS officials, and
scientific and professional personnel, intra-governmental counterparts
(State, territorial and tribal officials).
9. Prepares and reviews legislative proposals, Congressional
testimony; and materials related to implementing, amending, or
modifying the Family Smoking Prevention and Tobacco Control Act, FDA
laws, and regulations in collaboration with the Office of the
Commissioner, Office of Legislation.
10. Provides advice and analysis for international tobacco control
policies and acts as the Center's liaison with international
stakeholders, including foreign governments.
11. Advises external stakeholders, including large and small
tobacco manufacturers, tobacco control advocacy groups, medical and
professional trade associations, State, territorial, local, and tribal
governments, and others concerning the policy implications of the law
and regulations.
12. Manages the Center's small business assistance activities.
Office of Regulations (DID)
1. Provides Center's oversight and leadership in, and coordinates
the development of regulations, policies, procedures, and guidance
related to the regulation of tobacco products.
2. Reviews and clears draft regulations developed by the Center,
other FDA Centers, and other agencies.
3. Provides Center-level leadership and coordination for briefings
within FDA, and with HHS, OMB, and other Federal agencies related to
regulations and guidance documents.
4. Serves as the Center's focal point for developing and
maintaining communications, policies, and programs with regard to
regulations development, review, clearance, and publication.
5. Serves as the Center's primary liaison with the FDA's Office of
Chief Counsel and the HHS Office of General Counsel; and provides
support for legal defense in litigation.
6. Manages the development and implementation of plans for the
Center's regulation development activities.
7. Provides technical assistance on the development of legislative
proposals related to FDA responsibilities of the Family Smoking
Prevention and Tobacco Control Act.
8. Manages the citizens' petition process on behalf of the Center.
9. Supports the Center in its regulatory litigation activities.
Office of Science (DIE)
1. Conducts scientific research and reviews programs to support the
Center's goals for implementing the Family Smoking Prevention and
Tobacco Control Act, as part of a comprehensive effort to reduce the
toll of disease, disability, and death caused by tobacco products.
2. Serves as the focal point for overall management of Center
activities related to science priorities and resources. Advises and
assists the Center Director, FDA Commissioner of Food and Drugs, and
other key officials on scientific issues that have an impact on public
health, policy, direction, and long-range goals, and on the functions,
capabilities, and management of scientific research facilities; and
participates with other Agency components in planning such facilities.
3. Coordinates the Tobacco Products Scientific Advisory Committee
which advises the Center Director, FDA Commissioner of Food and Drugs,
HHS Secretary of Health and Human Services, and other key officials on
certain issues related to the public health impact of tobacco products.
4. Organizes, plans, directs, and conducts research related to the
development, manufacture, testing, labeling, and marketing of tobacco
products in order to develop and maintain a scientific base for
establishing policies, tobacco product standards, and test methods
appropriate for the protection of public health.
5. Plans, directs, and conducts epidemiological research regarding
the initiation, use, and cessation of tobacco products and the impact
on the public health.
6. Coordinates targeted research to address Center priorities in
collaboration with leading scientists in other segments of FDA, other
Federal agencies, and the scientific community at large.
[[Page 78262]]
7. Plans, directs, and conducts research related to behavioral
science, including consumer behavior and consumer perception of risks
of harm from tobacco products.
8. Establishes and publishes a list of harmful and potentially
harmful constituents in each regulated tobacco product.
9. Develops policies and procedures governing the submission and
review of ingredient and constituent information for regulated tobacco
products and oversees their implementation.
10. Develops and implements policies and procedures governing the
submission and review of applications and postmarketing surveillance
studies for modified-risk tobacco products.
11. Develops and implements policies and procedures governing the
submission and premarket review of reports of substantially equivalent
tobacco products and applications for new tobacco products.
12. Develops and implements policies and procedures governing
submission and review of information regarding investigational tobacco
products.
13. Develops, maintains, monitors, and analyzes policies, programs,
and databases of adverse reactions to tobacco products.
14. Reviews, evaluates, and takes appropriate action on
recommendations concerning denial or withdrawal of marketing and
modified-risk authorizations for tobacco products.
15. Develops, in coordination with other Center offices, standards
for Good Manufacturing Practices regarding methods, facilities, and
controls for manufacturing, testing, and storage of tobacco products.
16. Participates, in coordination with other Agency components, in
inspections of manufacturing facilities for compliance with applicable
manufacturing and tobacco product standards.
17. Represents the Center in interactions with other government
agencies, State and local governments, industry, academia, consumer
organizations, Congress, national and international organizations, and
the scientific community on tobacco science and regulation issues.
18. Coordinates and provides guidance on science policy in program
areas that cross major Agency component lines and on scientific aspects
of critical or controversial issues, including Agency risk assessment
policies.
Office of Health Communication and Education (DIF)
1. Serves as a comprehensive health communication enterprise
developed as a part of a comprehensive effort to reduce the toll of
disease, disability, and death caused by tobacco products.
2. Develops, coordinates, and evaluates public health communication
and education activities in support of requirements of the Family
Smoking Prevention and Tobacco Control Act.
3. Serves as the central point for communication about the Center's
activities, campaigns, and key messages, including executing programs
and implementing strategies about the regulation of tobacco products
and the health risks associated with tobacco product use.
4. Ensures consistent branding, messaging, and strategic
communications for all Center public education output.
5. Provides effective collaboration and coordination with partners
and stakeholders on public health education and communications
programs.
6. Provides accurate and timely public health information and
education about tobacco products regulation and the requirements of the
Family Smoking Prevention and Tobacco Control Act.
7. Develops and manages informational materials for health
professionals and consumers, including Web pages and print media.
8. Manages Center's Web sites (Intranet and Internet).
9. Constructs risk communication messages in support of the
requirements of the Family Smoking Prevention and Tobacco Control Act,
using appropriate research methods.
10. Serves as the liaison between the Center and its stakeholders
on public health education and communication programs.
Office of Compliance and Enforcement (DIG)
1. Advises the Center Director and other Agency officials on legal,
administrative, and regulatory programs and policies concerning Agency
compliance and enforcement responsibilities relating to tobacco
products.
2. Coordinates, interprets, and evaluates the Center's overall
compliance and enforcement efforts.
3. Provides technical support and guidance in the development and
review of standards, regulations, and guidance related to compliance
and enforcement.
4. Develops, directs, coordinates, evaluates, and monitors
compliance and enforcement programs covering regulated industry.
5. Coordinates, develops, and directs State compliance and
enforcement programs.
6. Provides training of Federal, State, and territorial compliance
personnel.
7. Conducts field tests and inspections when necessary for
regulatory purposes and evaluates regulated industry activities to
assure compliance with regulations.
8. Provides advice to Agency field offices and commissioned
officials, and manages Center activities relating to legal actions,
case development, and contested case assistance.
9. Designs, develops, and implements Center programs to register
tobacco establishments and product lists.
10. Coordinates all field planning activities and issues all field
assignments for the Center.
11. Advises actual or potential manufacturers, distributors,
retailers, and importers concerning the requirements of the law and
regulations related to compliance and enforcement.
III. Delegation of Authority
Pending further delegation, directives, or orders by the
Commissioner of Food and Drugs, or the Director of Center for Tobacco
Products, all delegations and redelegations of authority made to
officials and employees of affected organizational components in effect
prior to this date will continue in effect in them or their successors,
provided they are consistent with this reorganization.
Dated: December 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-31383 Filed 12-14-10; 8:45 am]
BILLING CODE 4160-01-P