[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.

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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