[Federal Register: January 2, 2008 (Volume 73, Number 1)]
[Notices]
[Page 191-194]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02ja08-60]
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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.
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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,
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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