[Federal Register Volume 73, Number 1 (Wednesday, January 2, 2008)]
[Notices]
[Pages 191-194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-6257]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Center for Food Safety and Applied Nutrition; Statement of 
Organization, Functions, and Delegations of Authority

    Part D, Food and Drug Administration, Chapter DB, Office of 
Operations, Center for Food Safety and Applied Nutrition (DBF), 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 56005, November 9, 1995; 64 FR 36361, July 6, 1999; and 
in pertinent part at 57 FR 54239) is amended to reflect the 
restructuring of the Center for Food Safety and Applied Nutrition 
(CFSAN), Office of Operations (OO), Food and Drug Administration (FDA) 
as follows:
    I. Under Chapter DB, Office of Operations, delete in its entirety, 
the ``Center for Food Safety and Applied Nutrition (DBF).
    II. Establish a new Chapter DH, Center for Food Safety and Applied 
Nutrition (DH), under Part D to read as follows:
    DF.10 Organization. The Center for Food Safety and Applied 
Nutrition, FDA is headed by the Director, Food Safety and Applied 
Nutrition, and includes the following organizational units:

Office of the Center Director (DHA)
Office of Management Systems (DHB)
Office of Food Defense, Communication and Emergency Response (DHC)
Office of Food Safety (DHD)
Office of Cosmetics and Colors (DHE)
Office of Regulatory Science (DHF)
Office of Food Additive Safety (DHG)
Office of Compliance (DHH)
Office of Applied Research and Safety Assessment (DHI)
Office of Regulations, Policy and Social Sciences (DHJ)
Office of Nutrition, Labeling, and Dietary Supplements (DHK)

    DF.20 Functions.
    A. OFFICE OF THE CENTER DIRECTOR (DHA). The Office of the Center 
Director (OCD):
    Provides leadership and direction for all Center activities and 
coordinates programs with other Agency, Department and government 
agencies.
    Plans, administers, coordinates, evaluates and promulgates overall 
Center scientific, regulatory, compliance, enforcement and management 
programs, policies and plans.
    Provides leadership and direction for Center management, planning, 
and evaluation systems to ensure optimum utilization of personnel, 
financial resources, and facilities.
    Establishes and manages a program to maintain the highest level of 
quality and integrity for all Center laboratory studies and the 
processing of regulatory samples, and ensures that all Center 
laboratory studies subject to FDA's Good Laboratory Practice 
regulations are conducted in compliance with them.
    Coordinates and monitors the Center's overall research portfolio, 
including all research-related activities and inquiries and the 
development of strategic research program plans.
    B. SENIOR SCIENCE ADVISOR STAFF (DHA1). The Senior Science Advisor 
Staff (SSAS):
    Provides advice to the Center Director and Deputy Directors on 
issues related to the Center's research portfolio, facilities and 
equipment.
    Represents the Center and Agency in scientific and other 
professional forums, including international forums, on issues related 
to food laws, regulations, standards and science and policies.
    Provides leadership for the development of short-, medium- and 
long-term strategic research program plans.
    Provides advice, consultation, and management oversight to 
appropriate representatives associated with partnerships with academia 
and other consortia.
    Fosters partnerships and effective communication with academia, 
private industry, trade associations, public sector groups, 
governmental agencies, commodity groups, and professional 
organizations.

[[Page 192]]

    C. INTERNATIONAL AFFAIRS STAFF (DHA2). The International Affairs 
Staff (IAS):
    Provides advice to the Center Director and Deputy Directors on 
issues related to international policy and direction.
    Provides leadership on development of the Center's policies that 
impact on international and/or trade issues.
    Represents the Center and Agency in international forums on issues 
related to international harmonization of food laws, regulations, 
standards and science, and policies.
    Provides expertise and oversight over international trade 
negotiations pertaining to foods and cosmetics and the implementation 
of the agreements that emerge from those negotiations, including 
management of any trade disputes.
    Coordinates activities between the Center and other Federal 
agencies, foreign competent authorities, and relevant stakeholders on 
issues having international components.
    Coordinates international technical assistance and training 
programs.
    D. EXECUTIVE OPERATIONS STAFF (DHA3). The Executive Operations 
Staff (EOS):
    Provides support to the Center Director and Deputy Directors, 
including the coordination and preparation of briefing materials and 
background information for meetings, responses to outside inquiries, 
and maintenance and control of the Center Director's working files.
    Manages the Center's Freedom of Information Act activities, 
coordinating responses with other Center technical, regulatory, and 
policy units as well as developing direct responses. Provides 
correspondence control for the Center and controls and processes all 
agency public correspondence directed to the Center Director. Develops 
and operates tracking systems designed to identify and resolve early 
warnings and bottleneck problems with executive correspondence.
    Coordinates the Center's communications with the Agency, 
Department, and the other federal government agencies.
    Manages all Congressional activities including hearings, briefings, 
and inquiries (except for legislation).
    Acts as the focal point for all activities with respect to the 
Government Accountability Office (GAO) and the Office of the Inspector 
General.
    E. OFFICE OF MANAGEMENT SYSTEMS (DHB). The Office of Management 
Systems (OMS):
    Advises the Center Director on administrative policies and 
guidelines and scientific and technical information systems.
    Plans and directs all Center operations related to program 
planning, budget, financial, and security management, and laboratory 
safety and health.
    Performs management studies and evaluations, as necessary, 
throughout the Center.
    Provides technical support and building operations support 
management to the Center in the areas of supply, equipment, space, 
communications, printing, reproduction, mail, contracts and grants, and 
awards.
    Represents the Center's information technology (IT) needs to Shared 
Services and the Chief Information Officer (CIO). Provides support to 
critical in-house data systems.
    F. OFFICE OF FOOD DEFENSE, COMMUNICATION AND EMERGENCY REPONSE 
(DHC). The Office of Food Defense, Communication and Emergency Response 
(OFDCER):
    Provides Center leadership for food defense and counterterrorism 
activities in relation to that segment of the U.S. food supply that is 
regulated by the Food and Drug Administration (FDA). Serves as FDA's 
lead for directing, developing, and coordinating high quality outreach 
and education activities (in collaboration with Center Program offices) 
and as a resource to all stakeholders (e.g., consumers, industry, 
states, and other Federal partners) in relation to food safety, food 
labeling, and food defense.
    Leads the Center in coordinating, directing, and assisting other 
agency units with foodborne outbreak investigations and coordination of 
other emergency activities involving food, dietary supplements, and 
cosmetics.
    Provides direction for strengthening systems for conduct and 
coordination of risk analysis activities and related research 
associated with national and international food safety and food defense 
issues.
    Assists the Center's Chief Medical Officer (CMO) as an expert for 
the Center in public health medicine, including Human Subject 
Protection (HSP) and Health Hazard Evaluations (HHE's).
    Provides statistical and epidemiological support for Center and 
field research, extramural and regulatory programs.
    G. OFFICE OF FOOD SAFETY (DHD). The Office of Food Safety (OFS):
    Develops and implements policies, regulations, and guidelines 
related to food safety. Conducts food safety research related to 
chemical or microbial contamination.
    Administers the federal portion of the Federal/State cooperative 
programs. Provides toxicological evaluations and quantitative risk 
assessments related to the presence of industrial chemicals, process 
induced toxicants and toxic elements in food.
    Serves as the principal Agency liaison on food programs and 
policies with industry, Federal, State, foreign, and other 
organizations.
    Provides expertise in acidified and low acid food technologies, 
including the registration and evaluation of filed processes.
    Maintains the Interstate Certified Shellfish Shippers List and the 
Interstate Milk Shippers List.
    Serves as Agency liaison with State partners in administering the 
Federal portion of the federal/state cooperative retail food program.
    Develops and promotes the adoption and implementation of the FDA 
Food Code, the National Retail Food Regulatory Program Standards and 
related agency policy for sound public health practices.
    Provides technical support and outreach to FDA staff and other 
Federal, State and local officials on the Food Code and other agency 
guidance on retail food protection.
    H. OFFICE OF COSMETICS AND COLORS (DHE). The Office of Cosmetics 
and Colors (OCAC):
    Develops guidelines, regulations, and policies for cosmetics and 
color additives. Communicates policy, guidance, and other information 
on cosmetics and color additives to the public, affected industry, and 
other stakeholders including international regulatory bodies.
    Provides expert scientific and technical advice and support on 
cosmetic products and ingredients and color additives to other FDA 
units and other Federal, State, and local authorities.
    Administers the Color Certification program, including laboratory 
testing and methods research.
    Administers the Voluntary Cosmetic Registration Program.
    Provides leadership and works closely with other Agency units in 
the area of nanotechnology.
    I. OFFICE OF REGULATORY SCIENCE (DHF). The Office of Regulatory 
Science (ORS):
    Conducts laboratory science and research that support the FDA 
regulatory agenda.
    Develops laboratory-based methods to support regulations and 
related policy developments.

[[Page 193]]

    Provides technical support and expert advice on scientific issues 
related to policy and regulations.
    Originates, plans, and conducts research in the areas of food 
processing and packaging, food chemistry, food toxicants, food 
microbiology and cosmetics.
    Reviews regulatory actions for adequacy of evidence and accuracy of 
the science and technical procedures and findings.
    Provides technical information and assistance with laboratory-based 
methods and procedures to foreign governments and visitors.
    J. OFFICE OF FOOD ADDITIVE SAFETY (DHG). The Office of Food 
Additive Safety (OFAS):
    Serves as the Center focal point for scientific and policy support 
for the development of Agency-initiated regulations on matters 
pertaining to the provisions of the food and color additive sections of 
the Federal Food, Drug, and Cosmetic Act.
    Manages the Center's petition review processes (both those 
conducted in-house and under extramural contract) for food and color 
additives, and consultation/notification processes for GRAS (Generally 
Recognized As Safe) substances, food contact substances, and foods and 
food ingredients derived from recombinant DNA biotechnology. Evaluates 
safety information, compiles the administrative record supporting 
actions on petitions and other agency actions, and prepares Federal 
Register documents relating to petitions.
    Prepares and/or reviews documentation required by the Center to 
implement the National Environmental Policy Act (NEPA). Coordinates the 
Center review of documents prepared under NEPA by other Federal 
agencies.
    Serves as the principal Agency liaison on safety testing 
methodologies and protocol standards needed to evaluate the safety of 
food ingredients and on other aspects of regulatory decisions.
    Develops compliance policy, position papers, procedural 
regulations, regulatory guidelines, and advisory opinions on issues 
related to the safe uses of food additives, food contact substances, 
color additives, GRAS substances, biotechnology derived foods, and 
prior sanctioned substances.
    Responds to stakeholder inquiries and processes Freedom of 
Information requests in a timely and efficient manner. Consults with 
Center and other FDA laboratories regarding research relevant to the 
regulation of food and color additives and food ingredients.
    Manages the Agency's review and monitoring of identity, probable 
human exposure to, and toxicity information on food and color 
additives, food contact substances, and GRAS substances in current use. 
Recommends enforcement action or regulatory change as needed. Provides 
expert scientific and technical advice to other Office, Center, and 
Agency components as needed.
    Provides evaluation and participates in bioresearch monitoring of 
non-clinical laboratory studies and facilities to assure quality and 
integrity of data submitted to the Agency in accordance with good 
laboratory practices
    K. OFFICE OF COMPLIANCE (DHH). The Office of Compliance (OC):
    Serves as the primary contact between the Center and FDA's field 
organization, including the Field Food Committee.
    Has primary responsibility for management of compliance programs, 
field assignments, and work plans and maintains the center-wide 
compliance management and reference systems.
    Initiates and/or coordinates the planning, development, publication 
and promotion of field guidance documents for CFSAN-regulated food and 
cosmetic products to implement sound public health practices, food 
safety/security interventions, compliance/enforcement strategies, and 
regulatory programs; provides information, training and technical 
assistance to implement development of Center guidance and regulations.
    Reviews proposed regulatory actions and recalls for adequacy of 
evidence and consistency across programs. Oversees the development of 
compliance and enforcement strategies for emerging compliance 
challenges.
    Monitors and mines information from internal and external sources 
to identify trends or emerging compliance and enforcement-related 
issues that may influence the Center's area of regulatory 
responsibility. Provides data and other information on field 
accomplishments to support the Center's evaluation of programs and 
assignments, development of new assignments, assessment of the industry 
or any other relevant Agency purpose.
    Oversees, monitors and evaluates the food facility registration 
data base.
    Plans and develops approaches to administer regulatory 
responsibilities in the Interstate Travel Program and provides 
information, problem-solving and technical assistance to Agency and 
external organizations within this program.
    L. OFFICE OF APPLIED RESEARCH AND SAFETY ASSESSMENT (DHI). The 
Office of Applied Research and Safety Assessment (OARSA):
    Establishes and conducts a cohesive mission-relevant research 
program in the areas of toxicology, microbiology and molecular biology 
that will ensure the safety of the U.S. food supply and the 
establishment of sound counterterrorism measures.
    Provides Center and Agency leadership in reproductive toxicology, 
neuro/behavioral toxicology, immunotoxicology, in vitro toxicology with 
special emphasis on hepatotoxicity, virulence assessment, 
immunobiology, microbial genetics and molecular virology.
    Recommends, develops, and conducts the Center's research program 
goals and priorities on food safety threat agents, safety and health 
hazards to foods, nutritional supplements, chemical contaminants, 
natural toxicants, and metabolities.
    Serves as the Center's principal research liaison with other Agency 
units and with other organizations outside the Agency. Initiates and 
coordinates collaborative studies with Center stakeholders and 
coordinates development of long-term collaborative research planning 
with the Center, other Agency units, academic, and research components 
to achieve food safety and food defense.
    Provides support to the national toxicological program with 
planning and implementation of sub-chronic and chronic toxicological 
evaluations emphasizing dose response relationships. Provides expert 
scientific direction, guidance and support to the Center's regulatory 
and compliance programs and provides expertise in both food safety and 
food defense.
    M. OFFICE OF REGULATIONS, POLICY, AND SOCIAL SCIENCES (DHJ). Office 
of Regulations, Policy, and Social Sciences (ORPSS):
    Coordinates the development of all CFSAN regulations and guidance 
documents, and reviews and clears for CFSAN draft regulations and 
guidance documents developed by CFSAN, other Centers in FDA, or by 
other agencies.
    Resolves policy issues involving Center-regulated food or cosmetic 
products in collaboration with the Center Director, Deputy Directors 
and other senior managers.
    Provides economic analyses and conducts consumer studies to provide 
information about the impact and/or effectiveness of various options; 
these analyses and studies are used by CFSAN managers throughout the 
decision-making and evaluation processes.
    Serves as the Center focal point and provides a centralized 
monitoring, coordinating, and advisory function for the Center and U.S. 
government on policies involving sensitive, controversial, and complex 
food issues,

[[Page 194]]

including policies involving food derived from biotechnology.
    Advises Center officials on regulatory approaches and manages the 
development of periodic plans for the Center's regulation development 
activities.
    Develops legislative proposals related to food and cosmetic safety 
and defense; coordinates the Center's review of bills and proposed 
legislation, upon request; and coordinates the Center's technical 
assistance to Congressional or FDA Office of Legislation staff 
developing bills related to food and cosmetics, upon request.
    Manages the Center's compliance with the Information Quality Act, 
including responses to request for correction and reconsideration 
submitted under the Act.
    Advises Center staff concerning the administrative procedures for 
rulemaking, guidelines, guidance documents, and other policy documents, 
hearings and delegations of authority.
    Leads the Center's evaluation of existing regulations to determine 
whether they are efficiently or effectively accomplishing their 
intended purpose.
    Provides Center-level leadership and coordination regarding 
briefings with other parts of the Agency or Federal Government with 
clearance responsibility regarding CFSAN regulations and guidance 
documents, and other CFSAN documents subject to the Paperwork Reduction 
Act, in coordination with the Executive Operations Staff.
    Directs and manages Center programs involving the use of external 
scientific advisors, consultants, and committees.
    Counsels and coordinates with Center managers on the use of 
external scientific experts and resources.
    N. OFFICE OF NUTRITION, LABELING, AND DIETARY SUPPLEMENTS (DHK). 
The Office of Nutrition, Labeling, and Dietary Supplements (ONLDS):
    Primary responsibility for policy development and management of 
food and nutrition labeling, food standards, conventional foods, 
dietary supplements, and special nutritional (including infant formula 
and medical foods) food.
    Provides expert advice to the Center Director, other Deputy 
Directors, and other senior managers, and directs major Agency and 
Department nutrition and labeling initiatives and is the Delegate to 
national and international forums and conferences.
    Primary responsibility for policy and regulatory development and 
management of the food labeling program, including Nutrition Labeling 
and Education Act, Food Allergen Labeling and Consumer Protection Act 
and other Federal Food, Drug, and Cosmetic Act and Fair Packaging and 
Labeling Act labeling requirements.
    Provides scientific and technical review of and response to 
petitions and notifications related to all aspects of conventional food 
labeling. With the Office of Compliance, determines compliance with 
existing food standards and common or usual name regulations and issues 
temporary marketing permits to allow manufacturers to test market new 
foods. In addition, conducts scientific and technical review of 
enforcement and compliance materials including inspection reports, 
analytical reports and other pertinent records, and provides policy 
decisions on misbranding charges for all domestic and import actions, 
including infant formula and medical food manufacturers.
    Provides expert guidance for other Agency units and Federal and 
State officials and industry concerning regulatory requirements and 
compliance policies on food labeling (including infant formula and 
medical foods) and reviews proposed enforcement/compliance actions 
referred by other agency units.
    Provides expert technical advice for participation in international 
forums.
    Reviews food product labeling (including infant formula, medical 
foods and nutrition labels) for adherence to regulations and 
appropriateness of claims and manages the Small Business Nutrition 
Labeling Exemption Notification Program.
    Provides scientific review and analysis of policies, regulations, 
research priorities, position papers, and advisory opinions on issues 
related to nutrition and nutrition labeling, and dietary guidance 
recommendations, and related nutrition science issues.
    Responsible for scientific and regulatory review of health claim 
petitions, qualified health claim petitions, nutrient content claim 
petitions, and FDA Modernization Act notifications for health claims 
and nutrient content claims.
    Provides expert advice and assistance to key officials and 
coordinates with other domestic and international scientific bodies on 
efforts related to nutrition and health.
    Identifies program priorities for, provides content design input 
to, and analysis of large-scale databases of food consumption, food 
composition, food ingredients, sales of processed packaged food 
products and product label information. Develops methods for monitoring 
US populations and special subgroups relative to use and safety of 
conventional foods and dietary supplements.
    Provides management and scientific review on issues related to 
infant formula, medical foods, and dietary supplements including 
petitions and notifications, and provides advice to key Agency 
components as well as international bodies.
    Responsible for the development of regulations, guidance, policy, 
programs, position papers and advisory opinions, and recommends 
research priorities for the management of the dietary supplement 
program, which includes safety assessments for the New Dietary 
Ingredient Notification Program, structure-function notifications, 
Certificates of Export, safety assessment for dietary supplement 
policy, responses to petitions and industry-related notifications, 
post-market adverse event evaluations, and issues related to dietary 
supplement safety and nutrition.
    III. Delegations of Authority. Pending further delegation, 
directives, or orders by the Commissioner of the Food and Drugs, all 
delegations or re-delegations of authority to positions of the affected 
organizations in effect prior to this date shall continue in effect in 
them or their successors.

    Dated: December 20, 2007.
Michael O. Leavitt,
Secretary.
[FR Doc. 07-6257 Filed 12-31-07; 8:45 am]
BILLING CODE 4160-01-M