Office of Regulatory Affairs
(For Information Only, Field Request is Included in Each Program)

Historical Funding and FTE Levels

MISSION

FDA also maintains more than 120 resident posts distributed widely across the country.  These are smaller offices that serve primarily as a base for investigators so that FDA can have investigative staff widely dispersed to respond to emergencies whenever they occur, as quickly as possible to minimize any potential harm. FDA maintains offices and staff in 49 of the States, and in the District of Columbia and Puerto Rico.

FDA's request for funds to cover 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, while facing the reality of a competing tight labor market.  Payroll costs significantly impact all FDA activities as it accounts for over 60 percent of the Agency’s total budget. 

With the pay increases, the Agency can support its ability to fulfill its mission of protecting the public health.  The Field Activities portion of this increase is $9,103,000.  Without the pay increase, the significant inroads that were made with the counterterrorism supplemental will significantly reduce 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. 

Counterterrorism - Food Safety: + $17,000,000

FDA must have the capacity to quickly and accurately identify outbreaks that may be happening or about to occur at any point in the food chain, and take prompt action to mitigate their effects. In the event of an identified threat, FDA will deploy emergency response teams who will work with other Federal, state, and local agencies to (1) focus on the potential risks related to FDA regulated products associated with a terrorist event; (2) work with other law enforcement agencies and related health risk management agencies; and,  (3) evaluate warehouses and manufacturers that regulate products in the vicinity of the event to make sure no regulated products have been compromised.  FDA believes by coordinating a laboratory response network that we will have a better means to identify and contain outbreaks associated with deliberate attempts to contaminate the food supply. FDA will also provide grants to States for inspections under section 311 of the Bioterrorism Preparedness and Response Act, improve Field laboratory preparedness, and develop and implement a Food Registration system as required by the Bioterrorism Preparedness and Response Act. With the increase in FY 2004, FDA will fund the following ORA activities in State Contracts and Grants, Laboratory Preparedness, and the Food Registration System.

The events of September 11, 2001 made the Nation more aware of vulnerabilities to the security of the U.S. food supply.  Congress responded by passing the Public Health Security & Bioterrorism Preparedness and Response Act of 2002 (“the Bioterrorism Act”)(PL107-188), which President Bush signed into law on June 12, 2002.  Title III of this act calls for the HHS Secretary, via FDA, to develop regulations for the following four provisions: (1) Section 303-Administrative Detention, (2) Section 305-Registration of Food Facilities; (3) Section 306-Establishment and Maintenance of Records; and, (4) Section 307-Prior Notice of Imported Food Shipments.  To date, Congress has not appropriated funds for this act.  For FY 2004, FDA requests $10,500,000 to continue implementation of a prior notice and food registration system.

Homeland Security:  - $234,000

Reflects an adjustment of $583,000 to the FY 2003 base in support of the Department of Homeland Security (DHS).   DHS will distribute these funds to States and major cities to support counterterrorism activities such as increased preparedness by hospitals and public health systems. The objective is to improve local preparedness, with national resources ready to be deployed immediately whenever and wherever needed.  The Field Activities portion of this is $234,000.

Vigilance must be maintained in 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.  With the requested increase, FDA will fund the following Field activities:

President's Management Agenda

The President's Management Agenda, announced in the summer of 2001, is an aggressive strategy for improving the management of the Federal government. It focuses on five areas of management weakness across the government where improvements and the most progress can be made to deliver results to the American people.  It reflects the Administration’s commitment to achieve immediate, concrete, and measurable results in the near term, while focusing on remedies to serious problems, and commits to implement them fully.  The following areas are FDA’s contribution in FY 2004 towards meeting this aggressive strategy.

Improving Management:   - $4,914,000

FDA recently estimated the total costs for GSA rents in FY 2004. Because of the substantial amount of additional space currently being requested or acquired, we expect fairly significant cost increases. Given the time it takes to acquire new space, and variations in the rental rates, the FY 2004 estimate for GSA Rent is $10,000,000 over the FY 2003 current estimate. FDA anticipates having to redistribute an as yet undetermined share of the FY 2003 resources for GSA Rent.

Management Savings:  - $10,435,000 and - 98 FTE

FDA has taken FTE reductions across the board, in the centers, field, and administrative areas.  The FTE in FDA's counterterrorism program were not affected by the management savings. The current freeze on administrative hiring will be helpful in reaching our FTE reduction, by not filling current vacant positions. Both administrative and scientific positions will be reduced through retirement and attrition.

While it is critical that FDA have the staffing levels to address added responsibility as a result of recent Congressional action, including the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, FDA believes the FTE reductions have been equitably taken across all areas, except for counterterrorism.  The Field Activities portion of this is $10,435,000 and 98 FTE.

Information Technology Consolidation:  - $12,664,000

FDA's FY 2004 President's Budget includes funding to support Departmental efforts to improve the HHS Information Technology Enterprise Infrastructure.  The request includes funds to support an enterprise approach to investing in key information technology infrastructure such as security and network modernization.  These investments will enable DHHS programs to carryout their missions more securely and at a lower cost. Agency funds will be combined with resources in the Information Technology Security and Innovation Fund to promote collaboration in planning and project management and to achieve common goals such as secure and reliable communication and lower costs for the purchase and maintenance of hardware and software.

FDA's budget request to Congress includes savings totaling $29,587,000 million in the IT budget from both ongoing IT infrastructure consolidation efforts ($15,000,000) as well as reduced developmental costs through the consolidation, streamlining, postponement or elimination of specific lower priority projects ($14,587,000).  Of the total IT budget reduction, the field accounts for $4,839,000 in IT infrastructure consolidation costs and $7,825,000 from reductions in developmental costs to Center and Field systems.

The Agency will fully implement its IT infrastructure consolidation by October 2003, therefore reducing infrastructure expenditure in FY 2004.  The CIO's office will look for opportunities that, based on a sound business approach using a rigorous cost benefit analysis, would benefit from the integration of new technology.  FDA seeks to reduce spending on specific systems across the entire Agency by identifying savings through one of three rationales:  consolidation or the combining of similar systems either within FDA/DHHS that will provide savings and reduce potential unnecessary duplication; streamlining or improved work processes and better project management; and, postponement or elimination of lower priority projects.  These improved processes will ensure that the Agency commits to the right projects for the right cost.

Restructuring:  - $2,717,000 and  - 22 FTE

As part of the Administration's goals to improve management operations of the Department of Health and Human Services, FDA has been actively implementing the initiatives as included in our restructuring plan submitted to the Department of Health and Human Services on November 30, 2001.  To reflect these restructuring efforts the FY 2004 budget request was adjusted for the Field  program for the following restructurings:

User Fees

Prescription Drug User Fee Act III (PDUFA): + $588,000

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 reauthorizes 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 of 2002 are effective for a five year period with certain technical improvements.  Specifically, Congress directed FDA to strengthen and improve the review and monitoring of drug safety; consider greater interaction between the agency and 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 Mammography Quality Standards Act (MQSA) was not authorized by the 107th Congress because FDA's FY 2003 appropriation was not finalized.  However, Agency staff has been working with Congressional staff and it is believed this issue will be resolved in the first quarter of the 108th Congressional session. The increase of $316,000 will provide for the impact of inflationary costs on the field portion of this program. 

MDUFMA is a multi-year enhancement effort to improve the quality and timeliness of the medical device review process.  It authorizes the collection of user fees for the review of medical device applications of $25,125,000 in the first year.  Those who submit premarket applications, certain supplements to those applications, and premarket notifications would pay the user fees.  The revenues would be used by FDA to expedite the review of such applications. The user fee increase will enable FDA to:

Counterterrorism

FDA must have the capacity to quickly and accurately identify actual or potential outbreaks occurring at any point in the food chain, and take prompt action to mitigate their effects. In the event of an identified threat, FDA will deploy disaster response teams who can work with other Federal, state, and local agencies to (1) eliminate or contain the hazard, and (2) reduce public health risk. 

Imports and Inspections

Since the emergence of the “global marketplace” in the last twenty years, imported foods constitute more than 10 percent of the U.S. food supply.  FDA data show that the number of imported food entries has doubled over the past seven years.  This explosion in the number of imported food entries 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.

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. 

Generic Drugs

Vigilance must be maintained in 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 

Premarket Activities

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

FDA works closely with the United States Department of Agriculture (USDA) and State agricultural and veterinary agencies on implementation of BSE regulations and controlling imported products.  FDA regulates many products that could contain this banned substance, including vaccines, cosmetics, and drugs, and has established a comprehensive monitoring system to identify products that may pose a health risk and ensure they not enter the U.S.

Internet Drug Sales

At present, there is 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.

An effective, comprehensive BioResearch Monitoring (BIMO) program is essential for the expeditious development and licensing of safe and effective products and to ensure patient safety. The Agency continues to leverage scientific capabilities in order to respond and contribute to major breakthroughs in pharmaceutical research and technology via continued professional development/ training, and continued stakeholder collaborations.

Prescription Drug User Fee Act (PDUFA)

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 reauthorizes 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 of 2002 are effective for a five-year period with certain technical improvements.  Specifically, Congress directed FDA to strengthen and improve the review and monitoring of drug safety; consider greater interaction between the agency and 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.

Mammography Quality Standards Act (MQSA)

The Mammography Quality Standards Act of 1992 was reauthorized in 1998 for an additional four years.  MQSA 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 fees collected pay for the costs of the annual inspections to ensure compliance with national quality standards. 

The Mammography Quality Standards Act (MQSA) was not authorized by the 107th Congress because FDA's FY 2003 appropriation was not finalized.  However, Agency staff has been working with Congressional staff and it is believed this issue will be resolved in the first quarter of the 108th Congressional session.

Post 9/11 Emergency Response: Increased emergency response capability through realigned resources for counterterrorism activities and strengthened emergency response plans.  The Agency worked closely with other federal, state, and local authorities and with regulatory agencies abroad to maximize coordination of efforts to protect the food and drug supply and to respond rapidly to evidence of threats.

Internet Commerce Initiatives-- Consumer Protection and Inhalation Anthrax:  Took steps to protect consumers from unscrupulous firms who attempted to exploit people’s fears by promoting unapproved and fraudulent products following inhalation anthrax incidents in 2001.  In coordination with the FTC, the Agency investigated hundreds of websites promoting products claiming to offer protection against various biological threats.  “Cyber” letters were issued to foreign firms advising them that FDA is taking steps to block the entry of the drug product, ciprofloxacin, into this country.  FDA asked U.S. Customs to detain entries of Ciprofloxacin from foreign firms because the Agency cannot ensure that drug products ordered from foreign websites are the same as those approved by the FDA. 

Information Disclosure and National Security Concerns: Began the process of developing a procedure entitled, “ORA Criteria for Assessing the Disclosability of Information in Light of National Security Concerns.”  This procedure identifies the steps necessary to determine if information should be disclosed or put on the Internet. 

International Inspection Procedures: Worked with State Department officials to develop an inspection process model focused on investigator safety, which will be used for the conduct of international inspections in countries for which a State Department warning has been issued.

AFDO Bioterrorism Workshop and Follow-up Regional Workshops: Organized a major bioterrorism workshop in conjunction with the Association of Food and Drug Officials (AFDO) national meeting in Portland, Oregon including representation from all fifty states.  The purpose was to establish working relationships between federal and state agencies to deal with bioterror threats or “events.”   A key outcome of these meetings was the establishment of Regional Laboratory Groups.  Four of these regional groups have already met; others are planning meetings.

Mobile Laboratories: Entered into an Interagency Agreement with the U.S. Army (Edgewood CBFAC) for the design and development of two mobile laboratories to be deployed at borders/ports or other locations where needed, to provide timely and efficient analyses of samples of FDA regulated products being offered for import into the U.S. and/or in the event of terrorist activity involving FDA-regulated products.

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.

Bioterrorism Analytical Capabilities: Developed analytical protocols for potential biological and chemical agents of terrorism.  Analytical equipment has been acquired for field laboratories that will enable FDA to handle large numbers of samples in the event of a terrorist contamination of foods or other regulated products. 

Bioterrorism Guidance:  Developed Product Safety and Integrity (PSI) or bioterrorism field examination criteria, implemented it in OASIS, and provided FDA field staff with a Q&A guidance document to help clarify bioterrorism procedures. 

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.  In FY 2002, participation in eLexnet was expanded to include 77 laboratories representing 45 states.  The process is underway to increase the breadth of coverage to include not only microbiological pathogens, but also other “analytes” that could endanger the food supply, including chemical agents, mycotoxins, and radionuclides.

Import Strategic Plan (ISP):  Began developing a Strategic Plan to re-engineer FDA's Import Programs.  One of the primary thrusts of this effort is to place responsibility for compliance with health, safety, and Good Manufacturing Practice (GMP) requirements on the importer and the foreign manufacturer rather than on testing by FDA at the time a product is offered for entry. 

Emergency Operations

Emergency Operations Center: Completed and opened the FDA Emergency Operations Center (EOC).  The use of new technologies was established in the EOC [secured fax, phone and shredder, time-zone clock, SmartBoard, and A/V Conferencing System], redundant communication [cell phones, Blackberries], and obtained Government Emergency Telecommunications System [GETS] cards for all emergency personnel.  FDA also developed requirements and drafted a contract for the Emergency Procedure Operations Network. The Emergency Operation Center responded to and/or coordinated the response to several incidents in FY 2002, including:

Inspection and Enforcement Initiatives

Internet Drug Sales:  Renewed cooperative agreements for Internet enforcement with the Federation of State Medical Boards and with the National Association of Boards of Pharmacy.  FDA issued 36 "cyber" letters and warning letters to firms promoting and selling fraudulent and unapproved products online.  The "cyber" letters have about a thirty percent positive response rate from the firms that are targeted.  Firms cited included ones found after a coordinated Internet “surf” selling products for protection against bioterrorism and unapproved drug and dietary supplement combinations.

Unlicensed Anthrax and Smallpox vaccines:  Assisted U.S. Customs in developing an Alert for Customs Inspectors to assist them in controlling the entry of unlicensed anthrax and smallpox vaccines and in developing and implementing cargo selectivity criteria for these products.

Good Laboratory Practice (GLP):  Signed a Voluntary Consent Agreement with a non-clinical laboratory in New Mexico.  FDA developed the consent agreement as an administrative action to achieve facility compliance with Good Laboratory Practice regulations.  The agreement is the first of its kind in the GLP program.

Recall Enterprise System:  Developed FDA’s first centralized database for recall information, which is being implemented on the intranet.  Specific information will be linked directly to the FDA Internet giving consumers “real time” recall information.

Filer Evaluations: Re-engineered FDA’s Filer Evaluation Program which will provide a statistical based method to evaluate firms and individuals who offer FDA-regulated products for import.

OASIS Import Data System:  Improved OASIS to permit staff to track FDA changes to filer transmitted data; Filer Evaluation History; to rescind admissibility decisions; to set up work for Priority Exams; and, to receive Package/Can Codes across the Customs interface.

Chlorampenicol in Imported Honey and Seafood Products: Established a sampling program covering imported honey and shrimp in response to reports of Chlorampenicol, a broad-spectrum antibiotic that is not approved for use in food producing animals and prohibited from extra-label uses in such animals, in imported honey and seafood.  To prevent contaminated products from entering the U.S., FDA has issued import alerts and worked closely with the U.S. Customs Service; both agencies have seized products before they could be entered into domestic commerce.

Dioxin Contamination of Animal Feed Mineral Supplements:  Determined that a mineral supplement used in animal feeds and widely distributed nationally and internationally, contained dioxins at unacceptable levels due to the manufacturing process used.  An investigation of other mineral supplement makers using similar methods is underway.

Bovine Spongiform Encephalopathy (BSE): Developed a compliance program that addresses domestic and import issues relating to use of prohibited animal protein used in animal feed.  The compliance program is geared toward preventing the spread of BSE and other TSE’s through feed and feed ingredients, and to assuring that prohibited material is not imported into the U.S.  The Agency conducted two nationwide training meetings for state and FDA investigators, and FDA and States conducted 6,195 BSE inspections during FY 2002.

BSE Prevention and Control:  Designed an inspection checklist geared to improve the Official Establishment Inspection Report (OEI) and provide the agency with a detailed report regarding a firms’ compliance.  FDA field employees were trained in the use of this new checklist and on the present BSE regulatory strategy.  

BSE Testing of Imported Animal Feed: Sampled and analyzed various types of imported feeds as a part of a continuing effort to prevent the spread of BSE to the United States.

Medical Gas Mix Up Prevention: Leveraged with homecare associations and firms to distribute information and posters titled "Won't Connect, Don't Connect" to prevent medical gas mistakes.  The posters will be used as part of the set for one episode of “Strong Medicine.”

Ephedrine-Containing Dietary Supplement Products:  Issued six Warning Letters for the illegal marketing of ephedrine-containing dietary supplements as unapproved drugs and warned another company to cease illegal promotion of an ephedrine-containing product as a street drug alternative.

Imported Candy Choking Hazard: Responded to several choking deaths associated with the consumption of imported candies known as mini-cup gel candies containing a product identified as “konjac.”  To ensure removal of these candies, FDA issued an import alert, two public warnings, supervised 15 Class I Recalls from 30 distributors across the U.S., and seized products at a wholesale distributor.

Egg Safety: Distributed over 301,000 brochures and 181,000 posters relating the risks of Salmonella Enteriditis (SE) in eggs to state and local officials, the regulated industry, FDA regional Food Specialists and Public Affairs Specialists.  The cooperating officials receiving this material are placing the publications in food and food service facilities in their States to educate food service workers on preventing SE-related illnesses.

MUCH Work Group on Health Fraud:  Co-Chaired the Mexico/U.S./Canada Health Fraud (MUCH) Work Group at the trilateral meetings in Mexico City, Mexico.  This group maintains a formal framework for trilateral cooperation in combating health fraud to protect the citizens of all three nations.

Canada-United States-Mexico Compliance Information Group (CUMCIG): Participated and made presentations on Emergency Response at the CUMCIG Meeting at Mexico City.

Partnerships and Support for States 

Small Conference Grants: Awarded $120,000 to 24 states to support their annual State Food Safety Task Force Meetings. 

Innovative Food Safety Grants: Awarded $365,643 to 10 state and local regulatory agencies for innovative food safety projects.  Over the past four years, FDA has awarded approximately $2.0 million for innovative inspection and educational programs, all designed to enhance food safety by reducing foodborne illnesses.

Small Scientific Conference Grants: Awarded $105,000 to support the annual meetings of the following organizations:  Association of Food and Drug Officials (AFDO); National Environmental Health Association (NEHA); Conference for Food Protection (CFP); and, the National Egg Regulatory Officials (NERO) Conference.

FDA's Broadcast/Fax Communications System:  Transmitted messages on Emergency Response/Counterterrorism; Product Recalls/ Warnings; Outreach; Training Courses for State Counterparts; and, ongoing concerns over Bovine Spongiform Encephalopathy (BSE) to state, local and federal regulatory counterparts.

Training Session: Offered vital information on radiological and x-ray inspection fundamentals to states, in conjunction with the University of Massachusetts.  As a result, 16 new x-ray inspectors, twelve for the states and four for FDA, were trained and have completed x-ray surveys which have helped to fulfill FDA-State partnership agreements.

State Contracts

Inspection Contracts: Awarded 40 state food contracts for over 7,100 food inspections costing $4.2 million; 34 feed manufacturing contracts for 3,300 inspections at a cost of $1.0 million; 19 tissue residue contracts for 619 inspections costing $371,000 and 48 MQSA contracts for 8,200 inspections costing $8.1 million.  A Milk Drug Residue Database contract was also awarded for $100,000, and two new Medical Device contracts were awarded in Texas and Colorado for a total of 95 inspections.

NMSU Laboratory: Contracted New Mexico State University (NMSU) to develop laboratory capability to assist FDA in areas where capacity expansion was needed.  The NMSU lab, through close cooperation with ORA, has staffed and equipped a microbiology lab to evaluate commercially-available rapid test kits for use in regulatory laboratories.  Two kits were initially selected and one evaluation is complete.

Training Initiatives to keep pace with Scientific Advances

ORA University: Trained over 800 FDA employees in over 50,000 web-based courses.  Fifty-three web-based courses have been made available with another twenty-five under stages of development.  The training for newly hired investigators and analysts was retooled to include web-based training, discussion questions, exercises, on the job training and audits.  The retooled training program has helped place these new hires on the street within 3 months of employment.

New Hire Training: Revamped New Hire Training Courses to meet FDA’s hiring initiatives to provide basic training to 800 new hires within six months.  Program includes WEB Based training, discussion questions, on-the-job training, exercises and Level I Certification Audit.

Training for FDA Staff:  Trained over 1,900 FDA investigators and analysts in 78 courses.  ORA continued implementation of investigator certification program.  Trained and standardized all supervisors to be Level I auditors and continued to deliver supervisory courses.

Good Laboratory Practice (GLP) Training:  Conducted three Good Laboratory Practice (GLP) training courses, the most recent training of which included scientists from the United States Army Research Institute of Infectious Diseases at Fort Detrick, MD, who are engaged in the development of bioterrorism agents.

Bovine Spongiform Encephalopathy (BSE) Exercise and Training:  Conducted an interagency test FDA’s BSE Response Plan.  Conducted an international satellite-training course on the BSE Contingency Plan.  Revised the BSE Response Plan and published it on FDA’s web site.  On November 14, 2001, a national satellite broadcast, entitled "BSE Import Safety Net", was presented to an audience comprised of FDA, US Customs Service and US Department of Agriculture inspection and compliance personnel.

TURBO EIR: Delivered over 20 Turbo EIR training courses to experienced and new hire investigators.  This course used a database on investigators’ observations on firm violations and to print an Inspection Report at the conclusion of an inspection.  It also allows for the automatic synchronization of Inspection Report data on the investigator’s notebook computer with network data.  

Training for State Officials:  Trained approximately 850 state personnel in 52 courses to further compliance with FDA policies and procedures and to help FDA meet its commitment to work proactively with state agencies to protect the public health. 

CEU Accreditation:  Became an Authorized Provider for Continuing Education Credits to the International Association for Continuing Education and Training (IACET) Organization.  All courses sponsored by ORA will offer CEU’s.

Verbal Judo:  Initiated a nationwide training program geared toward investigator safety, inspection techniques, and enhancing our investigators’ ability to diffuse potentially hostile situations by using verbal techniques.

Human Tissue: Developed a human tissue training course to train up to 90 individuals in two sessions in preparation for the full implementation of registration and inspection of human tissue banks.

Office of Criminal Investigations

Office of Criminal Investigations: Made 235 arrests that lead to 212 convictions.  During FY 2002, fines and forfeitures totaled more than $929,744,951.

Internet Initiative: Initiated 69 cases resulting in 27 Internet arrests, and 12 Internet convictions. 

Counterterrorism: Participated in Counterterrorism Task Forces including the FBI’s Joint Terrorism Task Forces (JTTF) in several cities, four agents detailed as Federal Air Marshals following the events of September 11th; investigative responses to numerous reports of suspected select agent contamination of regulated products; meetings increased dialogue with domestic and foreign law enforcement agencies and regulated industry; and, enhanced communications and contacts with the U.S. intelligence community.  All OCI agents have been granted national security clearances.

Improved Financial Management:  Completed the consolidation of Agency Location Codes (ALC) and began operating using one ALC at Headquarters and combining twenty-five accounting points into seven (one at Headquarters, NCTR, and one in each Region).  The ALC Unification Project improves field office accounting functions by creating new “Fiscal Offices” located in Atlanta, Buffalo, Chicago, Cincinnati, Dallas, Denver, Kansas, Los Angeles, Nashville, NCTR and Stoneham.  Each Fiscal Office will handle all field accounting functions and follow new standard operating procedures to prepare for the new financial system.

Strategic Management of Human Capital: Pioneered the use of the Office of Personnel Management Quick-Hire system for the rapid review and rating of external applications.  This process facilitated the review of over 4,000 applications and the certification of over 2,000 applications in record time, which enabled FDA to achieve the FY 2002 counterterrorism hiring goal of 655 employees for the field.

Competitive Sourcing: Participated in all aspects of planning and execution of Agency-wide studies under OMB circular A-76.

Expanded E-government: 

Made fifty-three courses available to FDA employees over the web, with an additional 20 courses currently under development.  FDA is working to make these courses available to state employees in FY 2003. 

Delivered satellite programs to a wide viewing audience on Fish and Fishery Products Hazards and Control Guidance, Information Disclosure – FDA’s FOI Document Repository, New Drug Process Inspections and Personal Safety Training for Field Personnel, ICH Q7A “Good Manufacturing Practice Guidance for Active Pharmaceuticedients and Its Use During API Inspections.”

Office of Regulatory Affairs
Performance Goals

Field Foods
Program Activity Data

Field Cosmetics

Field Human Drugs
Program Activity Data

Field Biologics
Program Activity Data

Field Devices and Radiological Health
Program Activity Data