MISSION

• Conducting investigational, inspectional and laboratory functions to ensure that FDA- regulated products are in compliance with the laws and regulations that FDA is charged with enforcing;
• In conjunction with the Centers, identifying the public health risk of violations of the Food, Drug and Cosmetic Act and its implementing regulations so that appropriate action is taken;
• Responding rapidly to emergencies, and redirecting field efforts, as necessary, to respond to unforeseen events;
• Managing and conducting criminal investigations within the Agency's jurisdiction, including advising and assisting the Commissioner and other key officials on legislation and policy involving criminal justice matters;
• Monitoring clinical research and conducting inspections of FDA-regulated products before they are marketed to ensure that manufactured products will be safe and effective;
• Performing field examinations of imported products to determine whether import entries comply with FDA regulations; and,
• Serving as FDA's primary liaison with consumers, health professionals, the media, states, and the regulated industry and trade associations to disseminate information on the products the Agency regulates.   

BACKGROUND

The Office of Regulatory Affairs (ORA) is the lead office for all FDA field activities.  Each of FDA's five major program areas has a complementary field component responsible for supporting the Centers in compliance with FDA regulations.  ORA accomplishes this through the inspection of regulated products and manufacturers, conducting sample analysis on regulated products, maintaining import data entry systems, and advising key officials on regulations and compliance-oriented matters that have an impact on policy development and execution, and long-range program goals.

The Field is staffed by about 4,000 people, over 90 percent of who work in five Regional Offices, 20 District Offices, 13 laboratories, and 130 Resident Posts. OCI personnel are located throughout the field organization in Field Offices, Resident Offices and Domiciles, which are located in 26 cities throughout the U.S.  FDA maintains offices and staff in all states except Wyoming.  Offices are also maintained in the District of Columbia, the U.S. Virgin Islands and Puerto Rico.

ORA's work involves conducting inspections, in support of the Agency's premarket activities for human and animal drugs, biological products and medical devices.  In addition, foreign and domestic inspections of establishments can include bioresearch monitoring of clinical research; preapproval inspections and laboratory method validations needed for premarket application decisions; and, inspections of manufacturing facilities to determine if the factory is able to manufacture the product to the specifications stated in the application.

To complement these premarket activities, the largest portion of ORA's work involves conducting domestic and foreign postmarket inspections of foods, human drugs, biologic, animal drug and feed, and medical device manufacturers to assess their compliance with Good Manufacturing Practice and biennial inspection requirements. ORA also monitors and samples imports to ensure the safety of the food supply and medical products. 

In addition to overseeing regulated products on a surveillance or "for cause" basis when a problem is encountered, ORA staff also responds to emergencies and investigates incidents of product tampering and terrorist events or natural disasters that may impact FDA regulated goods.

To complement the regular field force, the Office of Criminal Investigations (OCI) investigates instances of criminal activity in FDA-regulated industries.

Field Activities Program Increase for FY 2005
By FDA Strategic Goal

PROGRAM RESOURCE CHANGES

Budget Authority

Cost of Living - Pay: +$6,544,000

FDA's request for pay cost increases is essential to accomplishing its mission .Without a specially trained national cadre of scientific staff, FDA's ability to adequately carry out the mission of protecting public health and providing consumer safety will be compromised. FDA must maintain staffing levels and scientific capabilities that meet the demands of an increasing workload and new challenges .Payroll costs, which account for over 60 percent of our total budget, significantly impact all FDA activities.

The total Agency request for pay increases is $14,352,000.The field activities portion of this increase is $6,544,000.Without this, the FDA's ability to fulfill its mission to protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use, will be significantly reduced.

Food Defense - CT:  + $40,500,000 and + 80 FTE

FDA must uphold its responsibility for ensuring the safety of approximately 80 percent of the nation’s food supply. The total Agency request for Food Defense is $65,000,000 and 109 FTE. The Field’s portion of this increase is $40,500,000 and 80 FTE. The possibility of food products being used as a vehicle for attack is particularly worrisome because such an event potentially affects everyone in the U.S. FDA must have the capability to assess and then reduce risks associated with unexpected and potentially widespread health and safety threats. Resources would allow the FDA to invest in the protection of citizens by:

• Integrating the Food Emergency Response Network (FERN) with the nations' food testing laboratories and complementing CDC's Laboratory Response Network (LRN) to detect routine threat agents in food.  FERN will strengthen both Federal and state food testing capabilities; increase lab surge capacity to handle a terrorist attack or a national emergency involving the food supply; and, support recalls, seizures, and disposal of contaminated food to provide assurance that the impacted food is safe for consumption.  FERN, LRN and National Animal Health Laboratory Network (NAHLN) will work together to ensure appropriate response in all emergencies.
• Providing equipment, supplies, training and security to enhance state capability to assist in FDA's Food Security activities;
• Providing for laboratory testing to validate new methods and for technology transfer and proficiency testing programs to standardize intra and inter-agency laboratory performance; and,
• Build upon the substantial strides during the past year by completing the expansion of available data and providing needed security and real-time communication features in eLEXNET, a food laboratory IT network for the real time sharing of information on a national basis.  eLEXNET supports the FERN and can be interfaced appropriately with public health IT systems.   

Bovine Spongiform Encephalopathy (BSE):  + $6,675,000 and + 25 FTE

BSE or "Mad Cow Disease" is a deadly chronic, degenerative disorder affecting the central nervous system.  Feed containing remnants of the slaughtering process, such as the brain and spinal cord, may harbor the agent that causes BSE.  To ensure such substances are not contained in animal feed, and to prevent the establishment and spread of BSE through animal feed, the FDA finalized a regulation on August 4, 1997 entitled "Animal Proteins Prohibited from Use in Animal Feed".  Since 1997, the main focus of our BSE-prevention program has been regular inspections of all renderers and feed mills in the U.S. With the additional resources, FDA will:

• Increase funding of state BSE inspections, on-farm BSE inspections, and BSE monitoring and control infrastructure grants by $3,000,000 so that the states can perform an additional 2,500 inspections, improve state and federal information on the inventory of animal feed firms and firms handling prohibited materials, and strengthen state infrastructure to monitor and respond to potential feed contamination with prohibited materials;
• Increase funding for field BSE inspections, sample collections and analyses by $2,200,000 to support an additional 920 risk based BSE inspections and an additional 600 targeted sample collections and analyses of animal feed or feed components;
• Increase the funding of field investigator training, state coordination, and industry outreach by $1,475,000 to expand investigational efforts to industry sectors vulnerable to cross contamination, such as truckers, on-farm mixers and distressed or salvaged food; improve data quality and data management practices so that FDA can better monitor industry compliance and improve the usefulness of state data; and conduct industry outreach to better inform industry of responsibilities and opportunities to prevent BSE from contaminating animal feed;
• Reinspect any firm found to be in violation of the regulation and inspect other potentially affected firms to determine compliance with the regulation;
• Enforce the feed rule by conducting targeted BSE inspections of all known renderers and feed mills processing products containing prohibited material, such as meat and bone meal, on a yearly basis;
• Maintain the database and new data entry procedures for BSE inspections, and new BSE inspection checklist to target firms for re-inspections and to collect better data from FDA and State inspectors; and,
• Develop and validate detection methods for prohibited mammalian protein in ruminant feed.

Medical Device Review: + $1,006,000 and + 7 FTE

The requested increase will provide the resources needed to allow FDA to reach the required appropriation level for FY 2005 under the MDUFMA Act. The total Agency request for Medical Device Review is $25,555,000 and 50 FTE. The Field Activities program portion of this increase is $1,006,000 and 7 FTE.This increase in budget authority, coupled with the user fee funds for the review of medical device applications, will enable FDA to meet the aggressive premarket performance goals committed to under the legislation.This involves expediting review times which will support our agency wide initiative to make innovative medical technologies available to the public sooner, and helping to reduce the costs of developing safe and effective medical products while maintaining FDA's high standards of consumer protection. The additional funds will be used by FDA to:

• Conduct pre-approval inspections for device manufacturers; and,
• Revise, update and maintain the currency of guidance documents for industry to reflect the complexity of emerging technologies such as nanotechnology, robotics, and demographic developments.

Medical Product Counter Measures - CT: +$450,000 and + 3 FTE

FDA, working together with sister agencies such as CDC and NIH as well as DOD, and interacting with industry, health care providers and consumers, is at the forefront of the public health response related to countering terrorism and must have sufficient resources (potentially employing all types of assets such as full time and contract employees and partnerships with contracting and academic organizations) to continue to effectively and innovatively respond to the increasing and intensive level of activity required. The total Agency request for Medical Counter Measures is $5,000,000. The Field Activities program portion of this increase is $450,000, which will allow FDA to expand surveillance on emerging pathogens and strengthen the infrastructure among local, state, and federal public health providers to support prevention, surveillance, and control programs.

Administrative Efficiencies: - $6,891,000 and - 59 FTE

To fully embrace the President’s Management Agenda, FDA is delayering its organizational structure, performing competitive sourcing reviews, modernizing its financial management system, and consolidating its information technology infrastructure. The Field Activities portion of these management improvements consists of - $6,891,000 and - 59 FTE from the Agency-wide 198 FTE (7.5%) administrative efficiencies.

User Fees

Prescription Drug User Fee Act III (PDUFA): - $3,194,000 and - 29 FTE

PDUFA authorized the FDA to collect fees from the pharmaceutical industry to augment appropriations spent on drug review. These additional resources were to be used to hire and support additional staff for the review of human drugs so that safe and effective drug products reach the American public more quickly. The Bioterrorism Act of 2002 reauthorized the collection of user fees to enhance the review process of new human drugs and biological products and established fees for applications, establishments, and approved products. The PDUFA amendments are effective for five years and direct FDA to strengthen and improve the review and monitoring of drug safety; consider greater interaction with sponsors during the review of drugs and biologics intended to treat serious diseases and life-threatening diseases; and, develop principles for improving first-cycle reviews.

• The Field program has had reduced assignments for pre-market inspections and laboratory analyses for the support process of the review of Human Drug Applications.  In FY 2005, the Field expects to utilize $5,046,000 and 29 FTE in PDUFA fees in the Human Drugs program, a reduction of $4,060,000 and 36 FTE from FY 2004; and,
• In the Biologics program, the Field program portion of the request is an additional $866,000 and 7 FTE to cover inflationary costs.

Medical Device User Fee and Modernization Act (MDUFMA): + $63,000 and + 2 FTE

Sound, risk-based review processes are imperative to ensure that medical devices on the market are safe and effective.To strengthen and expedite FDA’s medical device review process MDUFMA, was reauthorized in FY 2002 as multi-year effort to improve the quality and timeliness of the medical device review process through the use of user fees collected from those who submit premarket applications, certain supplements to those applications, and premarket notifications. These fees, which supplement appropriations for the medical device review program, will allow FDA to continue the following efforts:

• Acquire and train staff to meet a set of aggressive performance goals for expediting the review of medical device applications;
• Promote public health with major improvements in review of expedited submissions for medical devices; and,
• Make major improvements in review performance in areas where fees are collected, while maintaining performance in other areas.

Mammography Quality Standards Act (MQSA): + $234,000

Breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer deaths among American women.  Experts estimate that one in eight American women will contract breast cancer during their lifetime.  The MQSA was signed into law in 1992 to address the public health need for safe and reliable mammography.  The Act required that mammography facilities be certified by October 1994 to be able to remain in operation, and inspected annually to ensure compliance with national quality and safety standards.  The MQSA Program certifies mammography facilities and performs annual inspections to ensure that women have access to safe and effective mammography services.  MQSA was not reauthorized by the 107^th Congress because of concerns about the need to improve the skills of physicians reading mammogram's and the need for interpretive skills assessment to be added to existing MQSA continuing medical education requirements.  The FDA has been working with Congressional staff to address these concerns and reauthorization of MQSA is expected in the current Congressional session. The fees collected pay for the costs of the annual inspections to ensure compliance with national quality standards.  The increase of $234,000 will cover inflation.

JUSTIFICATION OF BASE

EFFICIENT RISK MANAGEMENT: THE MOST PUBLIC HEALTH BANG FOR OUR REGULATORY BUCK

Base resources will be used to conduct science-based risk management in all agency regulatory activities, so that limited resources can provide the most health promotion and protection at the least cost for the public. These activities will support:

Information Technology

• Field Accomplishments and Compliance Tracking System (FACTS):  FACTS is a central data repository for workload management, sample collections, sample analyses, information about firms regulated by the FDA, investigative operations, and compliance operations. A goal of the FDA is to ensure that field sites are supported by systems that effectively automate the daily activities of FDA personnel. FACTS consists of five major, interrelated functional areas: manage firms, manage miscellaneous operations, manage investigative operations, manage compliance, and manage laboratory operations;
• Turbo EIR:  FDA field investigators annually conduct approximately 17,000 establishment inspections. A requirement of the inspectional process is to report (in writing) certain types of adverse observations to the management of the inspected firm at the conclusion of the inspection. Turbo EIR will provide a standardized database of citations, and assists the investigator in preparation of the Establishment Inspection Report (EIR). Turbo EIR assists data collection on specific violations uncovered during the inspection. The inspection data is then uploaded to a central database and available for analysis and trending;
• Operational & Administrative System Import Support (OASIS):  OASIS automates the system for processing FDA-regulated imports and reduces processing time. Delays in FDA processing of imports significantly increase product storage and interest costs; delays also decrease the quality of perishable products destined for U.S. consumers.  FDA ensures that foreign-origin products seeking to enter domestic commerce meet the same standards as U.S. manufacturers and growers. FDA evaluates products offered for import, and makes admissibility decisions whether those products meet the applicable provisions of the Federal Food, Drug and Cosmetic Act;
• On-line Program Analysis System (OPAS):   OPAS is a data warehouse containing statistical summaries of field activity data for the past 13 years.  This data contains information on mostly domestic activities from FACTS and field data systems that preceded FACTS. Its internal data processing stores the information in multidimensional cubes that can be accessed by field staff that are not skilled in specialized computer query languages.  In addition to providing counts of inspections, sample analyses and other field activities, it tracks time and field FTE's for the PDUFA and MQSA user fee programs.  This system permits risk based analyses that are timely and consistent.  Ultimately, OPAS is designed to be shared with users in ORA and the Centers;
• ORA Reporting Analysis and Decision Support System:  ORADSS is a repository of ORA data from OASIS that contains several years of data on import lines.  It is designed to permit in-depth analyses of import data and be shared across multiple systems and by users in ORA and the Centers.  Ultimately, ORA's data warehouse will contain features of both the OPAS and ORADSS systems so that users can perform risk based analyses that are timely and consistent; and,
• Mission Accomplishment and Regulatory Compliance Services (MARCS):   The MARCS System is a comprehensive redesign and reengineering of two core mission-critical systems at FDA:  FACTS and the Operation and Administration Support System (OASIS). OASIS primarily supports the review and decision-making process of products imported into the U.S., while FACTS supports the investigation, tracking of compliance, and laboratory operations related to domestic operations under FDA purview. Both are legacy systems which execute on client-server platforms.

Imports

Since the emergence of the "global marketplace" in the last 20 years, imported foods have grown to constitute more than 10 percent of the U.S. food supply.  FDA data show that the number of imported food lines has doubled over the past seven years.  This explosion in the number of imported food lines combined with the security concerns raised by terrorism and counterfeiting incidents has increased the need to physically assess the status of imported products as part of the Agency's emerging import strategy.

• Review more than 11 million import lines representing different FDA regulated products for admissibility into domestic commerce;
• Develop rapid analytical methods of screening imports at the border and increase the number of import lines reviewed for admissibility into domestic commerce;
• Collaborate with Customs and Border Protection to monitor the importation of regulated products and follow-up on the status of products refused entry; and,
• Expand import surveillance at international mail facilities and courier hubs.

Domestic Inspections

Inspections and surveillance are the primary means of assuring the safety of marketed products.  Consumers rely on the FDA to prevent dangerous and unreliable products from entering commerce.

• Identify the food source and contaminant of food borne illness outbreaks ranging from chemical and microbiological, and physical hazards;
• Conduct state contract audit inspections to ensure consistent application of regulations nationwide by FDA and the States;
• Continue to fund State contracts, partnerships and grants related to FDA regulated products in order for FDA to inspect and monitor the food industry frequently enough to ensure application of appropriate preventative controls to ensure a safe, wholesome, and nutritious food supply for compliance and inspection activities;
• Maintain FDA's presence in its retail, State audits and targeted inspection activities, and increased State partnerships and grant activities;
• Replace outdated field laboratory equipment to improve the accuracy and timeliness of food product analyses to determine compliance with safety requirements;
• Share data with Federal, State and local partners to protect the food supply;
• Provide criminal investigation of reported product tampering, counterfeit products and other fraudulent criminal activities involving regulated products;
• Develop laboratory analytical methods to permit the analyses of products for chemical and microbiological hazards;
• Continue to analyze more than 8,000 food samples for pesticides and environmental contaminants;
• Continue to analyze market baskets of food products to assess the risks of contaminants in the nation's diet;
• Conduct inspections of registered animal drug and feed establishments; and,
• Conduct about 1,000 bioresearch monitoring inspections to support the drugs, biologics and device programs.

EMPOWERING CONSUMERS: IMPROVING HEALTH THROUGH BETTER INFORMATION

Base resources will be used to better enable consumers to make informed decisions weighing benefits and risks of FDA-regulated products. These activities include:

Health Fraud and Dietary Supplements

The Consumer Health Information for Better Nutrition (CHIBN) initiative is designed to foster two complementary goals concerning the labeling of food and dietary supplements: to encourage makers of conventional foods and dietary supplements to make accurate, science-based claims about the health benefits of their products, and to help to eliminate bogus labeling claims by taking on those dietary supplement marketers who make false or misleading claims.

• Support the CHIBN initiative, which seeks to make available more and better information about foods and dietary supplements, to help American consumers prevent diseases and improve their health by making sound dietary decisions;
• Participate in the FDA Task Force on CHIBN, which is developing a framework to help consumers obtain accurate, up-to-date, and science-based information about conventional food and dietary supplements.  This includes the development of additional scientific guidance on how the "weight of the evidence" standard will be applied, as well as, the development of regulations that will give these principles the force and the effect of law; and,
• Ensure enforcement activities focus on products with specific marketing strategies.  These are: herbal products illegally promoted as alternatives to illicit street drugs; unapproved new drugs marketed containing prosteroids and precursor steroids as dietary supplements; items which are unapproved new drugs marketed as "natural" treatment for viruses, including the herpes virus, and for cold and flu protection; dietary supplements with unsubstantiated structure function claims (examples include treatments for autism, treatments for mental retardation and epilepsy, sports performance enhancement, and aging); and, dietary supplements containing prescription drug ingredients.

Information Technology

Recall Enterprise System (RES):  The implementation of RES will provide the District and Centers with a centralized, Agency-wide recall database.  RES will also provide the public with access to timely recall information via the FDA web site, and include information that provides detailed guidance for industry regarding developing and providing the District with background recall information.

IMPROVING PATIENT AND CONSUMER SAFETY

Medical Product Safety

FDA believes that roughly half of the deaths and injuries associated with medical errors can be avoided by fully implementing its strategies.  Thousands of lives and billions of dollars can be saved. 

• Provide training for field staff to improve the information gathered through investigation of consumer complaints and reports of medical errors;
• Conduct investigations of reported errors to collect information program managers need to assess the error, and develop error reduction strategies with manufacturers and the medical community;
• Inspect hospital device reprocessors to determine compliance with regulatory requirements; and,
• Review adverse event and complaint files at manufacturers during inspections for compliance with FDA reporting regulations and to conduct follow up inspections on adverse event reports when information from the manufacturer is needed to evaluate the risks involved.

Generic Drugs

Vigilance must be maintained in the generic drugs area. It is critical to ensure that the generic drug is identical to, or bioequivalent to a brand name drug in all critical respects.

• Maintain field staff hired to increase inspections of domestic and foreign firms.  The staff will also be used to provide for team inspections (reviewer and inspector) to increase efficiency; and,
• Maintain coverage of imported generic drugs so that FDA can better monitor the quality of finished drug products and bulk drug substances entering the U.S. from overseas.
• Improve the quality and timeliness of product reviews by monitoring pre-approval inspections and expanding inspectional expertise in emerging technologies; and,
• Improve the scientific expertise of field investigators by providing training, information technology, and contract support to improve the scientific expertise of field investigators.  This training enables the investigators to conduct pre-market inspections that are essential to meeting pre-market review time frames.

Premarket Activities

To speed the availability of new products to consumers and to the market, the FDA must continue to focus on developing mechanisms to effectively and efficiently complete the review process.

• Improve the quality and timeliness of product reviews by monitoring pre-approval inspections and expanding inspectional expertise in emerging technologies; and,
• Improve the scientific expertise of field investigators by providing training, information technology, and contract support to improve the scientific expertise of field investigators. This training enables the investigators to conduct pre-market inspections that are essential to meeting pre-market review time frames.

Bovine Spongiform Encephalopathy (BSE)

FDA works closely with the USDA and state agricultural and veterinary agencies on implementation of BSE regulations and controlling imported products.  FDA regulates many products that could contain specified risk materials, including vaccines, cosmetics, animal drugs, and animal feeds, and has established a comprehensive monitoring system to identify products that may pose a health risk and ensure that they do not enter the U.S. 

• Provide Federal and state inspectors with up-to-date information on the BSE feed regulation; European Union regulatory issues; Animal Plant and Health Inspection Service (APHIS) authority; and best sampling practices;
• Leverage with state agencies by funding contract inspections of feed mills and renderers, and conduct compliance, follow-up, and audit inspections to state contracts; 
• Collect and analyze domestic and import feed and feed component samples for BSE-related contaminants to ensure proper labeling of animal feeds and feed components;
• Conduct annual BSE inspections of all known renderers and feed mills processing products containing prohibited material.  Any firm found to be in violation of the requirements of the regulation will be reinspected, and other potentially affected firms will be inspected to determine compliance with the regulation; and,
• Conduct sampling program for animal feeds domestically and those detained at U.S. ports of entry that contain ingredients possibly derived from contaminated animals.

Internet Drug Sales

At present, there are an exploding number of new web sites marketing FDA regulated products to the American consumer and medical professionals. FDA currently conducts only minimal levels of web-based oversight.

• Monitor potentially fraudulent Internet sites to identify targets for investigation and sampling of products;
• Conduct "undercover only" purchases of prescription drugs from Internet sites suspected of engaging in illicit drug sales, distribution, and/or marketing; and,
• Provide oversight of mail and courier packages entering the U.S. from foreign sources.

PROTECTING AMERICA FROM TERRORISM

Base resources will be used to strengthen FDA’s capability to identify, prepare for, and respond to terrorist’s threats and incidents.

FDA must have the capacity to quickly and accurately identify and respond to potential terrorist events occurring at any point in the food chain, or in the distribution chain of other FDA regulated products and take prompt action to mitigate their effects. In the event of an identified threat, FDA will work with other Federal, state, and local agencies to eliminate or contain the hazard, reduce public health risk, and identify those who perpetrated the attack.

• Develop surveillance capacity to rapidly identify a specific threat or attack on the food supply;
• Develop effective prevention strategies to "shield" the food supply from terrorist threats;
• Develop a capacity for rapid, coordinated response to a food borne terrorist attack;
• Intensify the review of products offered for import for safety and security issues;
• Intensify collaboration with Customs and Border Protection at ports on product safety and security issues;
• Expand the capacity and capabilities of field laboratories to analyze samples to support counterterrorism activities;
• Strengthen relationships with state partners and solicit interest in the expansion of contracting efforts with state laboratories to provide surveillance and reserve capacity related to counterterrorism activities;
• Expand field laboratory and contract activities to evaluate and develop existing and potential laboratory and field test kits for product contaminants;
• Inspect drug and vaccine manufacturers whose products may be stockpiled as part of the Governments counter terrorist efforts; and,
• Maintain new field staffing levels to work on counterterrorism initiatives with a focus on imports.

Information Technology

• Electronic Laboratory Exchange Network (eLEXNET):  eLEXNET is the nation's first Internet-based data exchange system that allows Federal, state, and local laboratories to electronically share food safety samples and test data for various food-borne pathogens. The laboratories are able to access eLEXNET, regardless of their current system environment or level of automation;
• ORA Enterprise Portal:  The ORA enterprise portal will consolidate all the information needed by FDA Import Reviewers in one place and facilitate seamless access to multiple data systems thus eliminating multiple logon points in this highly time critical mission; and,
• FDA Unified Registration and Listing System (FURLS):  The FURLS supports the requirements of the Bioterrorism Act of 2002 as it relates to Food Facility Registration, Drug Facility Registration and Listing, and Prior Notice of Food Shipments into the U. S.  FDA began this effort by identifying opportunities for unification between the FDA Drug Facility Registration and Listing requirements with those of the Food Facility Registration Requirements.

Imports 

• Continue to develop the Food Registration and Prior Notice systems that became  operational in the first quarter of FY 2004;
• Conduct approximately 800 inspections of foreign establishments;
• Evaluate the accuracy of information import filers provide to the FDA automated entry review system regarding regulated products offered for entry into domestic commerce; and,
• Continue to conduct food import exams of food products offered for import into the country.

STRONG FDA

Base resources will be used to pursue this strategic goal of ensuring a world-class professional work force, effective and efficient operations and adequate resources to accomplish the mission of FDA. With these resources, FDA will continue to utilize ORA-wide Quality Management System (QMS) to enhance the current approach to managing quality work processes and products. It relies on clear, uniform, and accessible criteria for work processes, for quality control, and for feedback and system improvement. The QMS focuses on the managers’ responsibility to manage quality-related systems and is based on internationally accepted quality system standards.

COUNTER TERRORISM AND FOOD DEFENSE FIELD ACTIVITIES

Operation Liberty Shield:  FDA participated in the federal government's nation-wide "Operation Liberty Shield" assignment from March 19 - April 16, 2003.  The assignment included domestic inspections of food and cosmetics firms; sampling of targeted food and cosmetic commodities based on risk/threat assessments; import examinations; and domestic and import reconciliation examinations.  Reconciliation exams were conducted to ensure that the targeted food/cosmetic was what it was purported to be; there were no unexplained differences in the quantity of products ordered and what was subsequently received; that there were no visible signs of tampering; and, that sampled products were not adulterated with contaminants of concern.   In addition, during each domestic inspection or import examination, FDA issued the agency's "Security Preventive Measures Guidance Documents". Even though the domestic part of the operation ceased on April 16^th, FDA continued to perform the import functions with heightened vigilance.

FDA/Customs Import Blitz Exams:  FDA and Customs and Border Protection (CBP) personnel collaborated to conduct a series of import blitz exams on mail shipments of foreign drugs intended for U.S. consumers. The exams, conducted at the at the international mail facilities in Miami, New York (JFK airport), San Francisco, and Carson City (Los Angeles) in July and August, 2003 revealed that these shipments often contained dangerous, unapproved drugs that pose serious safety concerns. In addition, FDA conducted its import entry studies in Detroit and Buffalo as part of its efforts to combat illegally imported drugs.

Electronic Laboratory Exchange Network (eLEXNET):  Continued the development and expansion of eLEXNET, the nation's first seamless data exchange system for food safety testing information.  At present, there are 101 laboratories representing 50 states that are part of the eLEXNET system, 55 of which are actively submitting data into this system. Additionally, the United States, Canada and Mexico have agreed to establish a trilateral eLEXNET pilot to assess the utilities of this data sharing laboratory network among food laboratories in Mexico and Canada.  We are continuing to increase the number of participating laboratories.

FERN (Food Emergency Response Network):  Jointly, FDA is working with USDA to develop appropriate mechanisms to enhance the capacity/capabilities of the FERN.  To this end, a Steering Committee has been developed to provide the initial infrastructure for FERN. Training has been offered to 100 employees from both FDA and States.  Several FERN committees have joined to insert a proficiency program to assure that training is ample and analysts are competent at performing the analyses once trained in the classroom. 

Import Prior Notice:  FDA and Customs and Border Protection (CBP) collaborated on the development of, and subsequently signed, a MOU allowing FDA to commission thousands of CBP officers in ports and other locations to conduct, on FDA's behalf, investigations and examinations of imported foods.  This unprecedented agreement significantly strengthened the implementation of the Bioterrorism Act in general, and the Prior Notice provisions specifically, to assure the security of imported foods.  FDA developed a web-based Prior Notice system to facilitate and streamline access by importers, domestic and international users of the system.  

Bioterrorism Outreach: FDA sponsored two world-wide public meetings via satellite downlink to explain the proposed Bioterrorism Regulations. The broadcasts were made available in English, Spanish and French and were shown at numerous sites across the nation, in addition to viewing sites in Canada, Mexico and South America. FDA also participated in over 80 domestic and international meetings with private trade groups and associations to explain the provisions of the regulations.

Mobile Laboratories:  Featherlite, Inc. of Cresco, Iowa was awarded the contract to build two mobile analytical laboratories in September of 2003.  These laboratories will provide flexible analytical capability that can be relocated easily to sites generating samples. 

Hazardous Sample Collection Team: Developed and implemented a process and procedure for the collection of hazardous samples, including the creation of a team of "second responders," who will collect samples of FDA-regulated products if associated with a terrorist or tampering event. Identified, secured, and completed the appropriate training and equipment needs for this team.The Agency presently has two secondary responder teams that are certified and trained in hazardous material identification, protective equipment, DOT shipping requirements, and applicable regulations.

Medically Necessary Products for Defense:  Worked closely with the Department of Defense (DOD) to assure that medically necessary products, e.g., Cyanide Antidote Treatment kits needed for the war in Iraq and domestic counter terrorism activities are available.  FDA assisted DOD on a multi-million dollar contract for the purchase of two anti-malaria drugs and arranged with Chicago District Office for an emergency warehouse inspection to assess storage conditions.

Established an Emergency Communications Network: Established a backup Communications network to function in the event that "land-line phones" become compromised in an emergency and to augment existing communication channels.  Cell phones and wireless e-mail communication devices that will be available in the event of an emergency on a separate cellular network, have been provided to the critical staff within FDA.  We continue to augment this network and have utilized it during the emergency response exercises.

Radiation Safety:  Implemented a "radiation pager program" for our import personnel to assure that import entries with radioactive material do not go undetected and to protect our employees. 

Food Security Outreach to Industry:  FDA and state officials continue to issue Food and Cosmetics Security Preventive Measures Guidance documents that recommend the types of preventive measures that companies can consider reducing the risk that products under their control will be subject to tampering, criminal or terrorist actions. FDA and state officials also discuss security awareness with each facility's management.

Bioterrorism Regulation Development:  ORA heavily participated in writing the final regulations for Prior Notice, Facility Registration, Administrative Detention of food and Record keeping requirements needed to implement the Bioterrorism Act published in December 2003.   

BOVINE SPONGIFORM ENCEPHALOPHATHY (BSE) FIELD ACTIVITIES

Bovine Spongiform Encephalopathy (BSE) Incident in Canada/Traceback on Pet Food: When Canada identified its first case of BSE, FDA and other Federal agencies included Canadian imports on the list of products that posed risks of transmission of BSE. Moreover, when the FDA learned from the government of Canada that rendered material from a Canadian cow that tested positive for BSE may have been used to manufacture pet food, some of which was shipped to the United States, FDA notified and worked with the U.S. distributor of the pet food firm to successfully recover the product before it was consumed.

BSE Injunction:  A Consent Decree of Permanent Injunction was entered into with X-Cel Feeds, Inc., Takoma, WA, and individual officers of the corporation.  The Consent Decree requires strict compliance with requirements designed to prevent potential contamination of ruminant animal feeds with prohibited mammalian proteins. This was the first injunction taken for violations of the 1997 regulation entitled, "Animal Protein Prohibited from Use in Ruminant Feed" that was issued to prevent the spread of BSE.

FDA Coordinates with States on BSE: FDA continues to leverage with state agencies by conducting training on the BSE feed regulation, establishing partnership agreements and funding contract inspections of feed mills, renderers, and others subject to the regulation, as well as conducting compliance and audit inspections. Through these efforts, FDA, along with State agricultural and veterinary agencies, has obtained a greater than 97 percent compliance rate with the BSE feed control regulations. The field met its FY 2003 performance goals by conducting inspections of 100 percent of the 880 firm inventories of renderers, protein blenders, and feed mills manufacturing or processing products using prohibited materials.

ENFORCEMENT FIELD ACTIVITIES

Ephedra-Containing Dietary Supplements:  FDA issued an Ephedra White Paper entitled, "Evidence on the Safety and Effectiveness of Ephedra:  Implications for Regulation."  FDA identified over 50 web sites that were promoting ephedrine-containing dietary supplements with unsubstantiated claims for athletic performance enhancement.  Twenty-six Warning Letters were issued to firms making such claims.

Internet Storefront Drugs from Canada:  FDA issued a warning letter to one storefront operation facilitating the Internet sale and importation of unapproved prescription drugs from Canada.  FDA also coordinated regulatory activities with state regulatory bodies and national regulatory organizations against storefront operations that import unapproved prescription drugs from Canada.

SARS Internet Claims: On May 9, 2003, FDA and FTC warned Web site operators, manufacturers and distributors to remove misleading or deceptive internet claims that their products may prevent, treat or cure Severe Acute Respiratory Syndrome (SARS). FDA sent Warning Letters to eight firms promoting dietary supplement products to treat or prevent SARS on the Internet.

American Red Cross Injunction:  Since 1993, the American Red Cross (ARC) has been operating under a Consent Decree of Permanent Injunction due to inadequate controls it had in place for its blood collection and distribution activities.  Following continued failure of ARC to come into full compliance with requirements, the Consent Decree was amended on April 15, 2003, to add monetary penalties for failing to comply with the decree requirements. When continued non-compliance was found, FDA followed procedures to impose monetary penalties.

Radiation Therapy Device Injunction: A Consent Decree of Permanent Injunction was entered into with Multidata Systems International Corp. and responsible individuals to enjoin this company from committing continued violations of medical device current good manufacturing practice and design standards involving this firm’s manufacture of radiation therapy devices. Previous failure of this firm to comply with such requirements had contributed to 28 patients receiving excessive amounts of radiation at a medical facility in Panama, with several deaths.

Interstate Sales of Diluted Cancer Drugs:  On December 5, 2002, in Kansas City, MO, a Federal judge citing Robert Courtney's gross indifference to patient safety and welfare sentenced Courtney to 30 years confinement and ordered him to pay $10,452,109.67 in victim's restitution. Courtney pled guilty to 20 counts of Drug Tampering and FD&C Act violations. Courtney was a pharmacist who diluted cancer drugs prior to filling prescriptions from doctors and clinics.

Internet Drug Sale Enforcement Actions:  FDA brought enforcement actions against several individuals selling prescription drugs without a doctor's prescription, individuals making fraudulent claims that their drug could cure cancer, and individuals selling unapproved drugs.  These actions resulted in prison sentencing of over 18 years.  FDA also issued eight Warning Letters to firms marketing alternatives to street drugs such as "ecstasy" on their web sites, and charged that these products are unapproved new drugs.

FDA/FTC Dietary Supplement Workgroup and Seizures:  In coordination with the Federal Trade Commission (FTC) and as part of "Operation Cure All", FDA initiated seizure actions against two products marketed as dietary supplements which made false and unsubstantiated claims alleging that they could treat or cure serious diseases including cancer, multiple sclerosis, lupus, heart disease, and diabetes, among others.  In June 2003, FDA initiated three separate seizures of Coral Calcium Supreme and Seasilver products with a combined value of $9.6 million.

Interstate Sales of Counterfeit Drugs:  FDA brought criminal action against individuals selling counterfeit drugs and prescription drugs without a wholesaler license.  These actions resulted in combined prison time of over 20 years and forfeiture of over $200,000 in assets. 

Criminal Indictment in Warehouse Case:  A five-count indictment was announced June 18, 2003, by the U.S. Attorney in the Northern District of Chicago, Illinois, charging three executives of LaGrou Distribution System, Inc., which operates cold storage food warehouses in the Chicago area, with storing more than 22 million pounds of adulterated meat, poultry, and other food products in unsanitary, rodent-infested conditions, and criminal conspiracy to violate federal public health standards.  This enforcement action was in addition to a 2002 seizure of approximately $10,000,000 of FDA and USDA-regulated foods stored under unsanitary conditions.

Chloramphenicol in Food Seizures:  FDA initiated seizures of foods contaminated with low levels of chloramphenicol, a potentially harmful antibiotic and unapproved food additive.  Separate investigations revealed that imports of some bulk Chinese honey and certain imported seafood products were contaminated.  This led to the seizures at three honey distributors, three crabmeat dealers, and one shrimp salad distributor.

STATE AND OTHER STAKEHOLDERS FIELD COLLABORATION

Monkeypox Outbreak:  FDA coordinated the activities of Federal, state and local agencies to respond to the introduction of the Monkeypox virus into the U. S.  Together these agencies directly contacted over 4,400 facilities to inform them of the order banning the sale, distribution, transport or release into the environment of prairie dogs and six African rodent species.  FDA is also continuing to implement the import embargo of rodents originating from Africa and the ban on bushmeat and the importation of trophy animals.

Contracts with the States:  Increased the spending level of food contracts with the states from $4.2 million to $5.5 million which includes $1.1 million for medicated feeds; $850,000 for tissue residues; and, $135,000 for the Milk Residue Database.

State Collaboration:  FDA has routine communication with its state contractors. FDA managed the electronic state Access to FACTS (eSAF) project. This new feature of the data system will allow state personnel to utilize the FACTS database to enter contract inspection data so that FDA will have more accurate and timely information on the compliance status of state monitored firms. Small Conference Grants were awarded in the amount of $102,600 to 21 states to support their annual State Food Safety Task Force Meetings.

International Cooperation:  Devised and implemented procedures for FDA District Offices to share non-public information with the European Community auditors during their audits of FDA inspections. ORA held discussions with Korea, Israel, and Canada regarding their requests to develop Memoranda of Understanding (MOU) on Good Laboratory Practices. FDA's international cooperative agreements with other Organizations of Economic and Cooperative Development member countries resulted in the other member countries conducting eleven non-clinical laboratory safety study audits in Germany, Spain, UK, and Switzerland. FDA co-chaired an International Interagency Health Fraud Steering Committee working on developing consensus programs geared toward a common goal of fighting health fraud nationally and internationally.

INSPECTIONAL, INVESTIGATIONAL, AND LABORATORY FIELD ACTIVITIES

Field Performance Goals:  The field met or exceeded all twelve of its Performance Goals, which included but were not limited to: 78,659 import food field exams; 7,363 inspections of domestic high risk food establishments; 1,594 inspections of registered domestic blood banks, source plasma operations, and biologics manufacturing establishments; 584 inspections of registered high risk drug firms; 847 inspections of the registered domestic animal drug and feed establishments; 1,428 inspections of registered domestic Class II and Class III medical device manufacturers; 225 inspections of registered foreign Class II and Class III medical device manufacturers; and, 364 medical device bioresearch monitoring inspections.

Foreign Inspection Activities:  A "model inspection process" was designed for conducting inspections in countries with an associated State Department Warning and Advisory.  The model includes added security, transportation, and coordination with the local U.S. Embassy in an effort to accomplish mission critical work without compromising the safety of FDA investigators. This model has been used on numerous foreign inspection trips and has proven to be an effective tool to assure that the Agency can accomplish high priority work under secure conditions.

Laboratory Accreditation:  Revisions to the laboratory quality manual and laboratory procedures manuals were completed. An accreditation audit was conducted at the Denver District Laboratory, resulting in the accreditation of this laboratory under ISO 17025, the first such successful accreditation in ORA.  Other labs will undergo the accreditation process beginning in early FY 2004.

Rapid Methods / Test Kits:  A contract was renewed with New Mexico State University to evaluate test kits to determine their suitability in FDA regulatory labs.  Evaluation of five rapid test kits, designed for detection of E. coli/coliforms including E. coli 0175:H7 and Staphylococcus in various food matrices was completed.  Currently, evaluations of test methods for Listeria and Shigella species are underway.

OASIS Import Data System:  Enhanced the Operation and Administration Support Information System (OASIS) to include new priority exams and sample screening; filer evaluation history; and improvements to the Screening Criteria Management Form.  This permits entry reviewers to better target products of risk.

PROGRAM ACTIVITY DATA CHARTS

FIELD FOODS

FIELD COSMETICS

PROGRAM ACTIVITY DATA CHARTS

FIELD HUMAN DRUGS

PROGRAM ACTIVITY DATA CHARTS

FIELD BIOLOGICS

PROGRAM ACTIVITY DATA CHARTS

FIELD ANIMAL DRUGS AND FEEDS

PROGRAM ACTIVITY DATA CHARTS

FIELD DEVICES AND RADIOLOGICAL HEALTH

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