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Field Activities - Office of Regulatory Affairs

<< Return to FY 2007 Budget Summary

 

  FY 2005
Actual
FY 2006
Enacted  2/
FY 2007
Estimate
Increase or
Decrease
Program Level $493,258,000 $503,951,000 $526,259,000 $22,308,000
  FTE 3,633 3,488 3,488 0
Budget Authority $477,568,000 $482,458,000 $504,029,000 $21,571,000
Foods $283,257,000 $285,153,000 $301,324,000 $16,171,000
Human Drugs $81,003,000 $79,919,000 $79,794,000 - $125,000
Biologics $26,514,000 $27,184,000 $28,776,000 $1,592,000
Animal Drugs & Feed $35,124,000 $34,842,000 $35,778,000 $936,000
Medical Devices $51,670,000 $55,360,000 $58,357,000 $2,997,000
Budget Authority
 
 
 
 
Pandemic Preparedness
 
 
$4,031,000 $4,031,000
FTE
 
 
18 18
Food Defense $12,270,000 $33,903,000 $51,301,000 $17,398,000
FTE
 
 
4 4
   Tissues
 
 
$1,238,000 $1,238,000
FTE
 
 
10 10
   Trigger Needs for ADUFA and MDUFMA 3
 
 
$2,049,000 $2,049,000
FTE
 
 
13 13
   Cost of Living
 
 
$8,297,000 $8,297,000
Strategic Redeployment
 
 
($11,442,000) ($11,442,000)
FTE
 
 
(48) (48)
User Fees $15,690,000 $21,493,000 $22,230,000 $737,000
PDUFA $6,138,000 $8,675,000 $9,074,000 $399,000
 FTE 32 41 43 2
MDUFMA $966,000 $1,194,000 $1,295,000 $101,000
 FTE 8 9 10 1
MQSA $8,586,000 $11,624,000 $11,861,000 $237,000
 FTE 8 8 8 0

This program narrative is shown for illustrative purposes only.  The five program narratives (Foods, Human Drugs, Biologics, Animal Drugs and Feeds, and Devices and Radiological Health) have a Field component included in them. 

 2  Includes a one-percent rescission. 

Historical Funding and FTE Levels
Fiscal Year Program Level Budget Authority User Fees Program Level FTE
2003 Actual $471,065,000 $456,148,000 $14,917,000 4,003
2004 Actual $528,853,000 $513,906,000 $14,947,000 3,872
2005 Actual $493,258,000 $315,562,000 $15,690,000 3,633
2006 Enacted $503,951,000 $482,458,000 $21,493,000 3,488
2007 Estimate $526,259,000 $504,029,000 $22,230,000 3,488

 

Statement of the Budget Request

 

The Office of Regulatory Affairs (ORA), Field Activities is requesting $526,259,000 in program level resources for accomplishing its mission activities including:

Conducting investigational, inspectional and laboratory functions to ensure that FDA-regulated products comply with the laws and regulations that FDA is charged with enforcing;

  • 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.

 

Program Description

 

The Office of Regulatory Affairs (ORA) is the lead office for all FDA field activities.  ORA supports each of FDA's five Centers by inspecting 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.

In FY 2007, ORA's budget will support approximately 3,300 people in the field and 170 people in the Office of Shared Services.  Newly proposed Reinspection and Export Certification User Fees will support 120 of these FTE.  Over 85 percent of ORA's staff works in five Regional Offices, 20 District Offices, 13 Laboratories, and 150 Resident Posts and Border Stations.  The Office of Criminal Investigations (OCI) personnel are located throughout the field organization in Field Offices, Resident Offices and Domiciles, which are located in 25 cities throughout the U.S.  FDA maintains offices and staff in the D.C., the U.S. Virgin Islands, Puerto Rico, and in all states except Wyoming.  FDA also monitors imported products traveling through 12 international mail facilities and 22 courier ports.

ORA's work involves conducting foreign and domestic pre-market and post-market inspections.  Pre-market activities can include bioresearch monitoring of clinical research; pre-approval 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 pre-market activities, the largest portion of ORA's work involves post-market inspections of foods, human drugs, biologics, animal drugs and feeds, and medical device manufacturers.  These inspections assess their compliance with Good Manufacturing Practice and biennial inspection requirements. ORA's radiological health activities include inspecting certified mammography facilities for compliance with the Mammography Quality Standards Act (MQSA).  It also includes inspecting radiological health products such as lasers, sunlamps, and x-ray equipment to ensure they are in compliance with performance standards. 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, ORA staff also respond to emergencies and investigate incidents of product tampering and terrorist events or natural disasters that may impact FDA regulated goods.  To complement the regular field force, the OCI investigates instances of criminal activity in FDA-regulated industries.

FDA relies heavily on its post-market investigation, inspection, and compliance activities to assure the safety and quality of the products it regulates.  ORA's Counter Terrorism (CT) program role includes safety and security of the food and feed supply; support of the development and manufacturing of vaccines and medical counter measures; the assessment of drugs and other medical products included in the Strategic National Stockpile Program; and, participation in and support for exercises and security preparations for public events such as the Olympics and National political conventions.  FDA's responsibilities for radiation safety and health give it a role in assessing x-rays used for security screening of packages and other radiation emitting products with medical or CT uses.  The Field provides emergency responses to illness and injury potentially linked to FDA regulated products; and, coordinates its activities with the Centers for Disease Control (CDC).  In addition, ORA inspections and investigations are essential to human tissue safety; BSE feed contamination prevention; counterfeit drug, infant formula and other product investigations; and, dietary supplement safety enforcement.  

The Field coordinates import activities with the Department of Homeland Security's Customs and Border Protection (CBP) Agency.  The number of FDA regulated imported products is increasing exponentially.  This would challenge FDA's ability to provide an appropriate response even if security concerns were not taking an ever increasing role.  In FY 2007, FDA is projecting a total of 19.8. million import lines.  These are 60 percent food products; 8 percent cosmetic products; 2 percent human drugs and biologic products; 1 percent animal drugs and feeds products; and, 29 percent medical device and radiological health products.  ORA uses a combination of electronic information technology for risk based screening and staff intensive surveillance; physical examinations; and, laboratory analysis to make import entry decisions.

 

Performance Analysis 

 

During FY 2005, which was the latest performance period, the Office of Regulatory Affairs (ORA) successfully achieved or exceeded all 14 targets for its FY 2005 performance goals.  For more information about these performance goals and results, please see the Performance Detail section.

For FY 2006, ORA adjusted the performance goal targets due to the catastrophic natural disasters that affected the southeastern portion of the United States.  This allows the field personnel in the affected area to focus on disaster recovery and revitalization rather than on traditional performance goal activities. 

For FY 2007, it is assumed the field will return to normal operations for performance goals except in the Import Food Field Exams goal which decreased by 4,000 exams as a result of redirection of funds to other food defense priorities. 

ORA added a new performance goal target to the existing biologics performance goal to highlight the accomplishments in the Human Tissue inspection area. In Medical Devices, the two performance goals, foreign inspections and domestic inspections, were combined into one performance goal to better reflect the overall inspectional coverage.

The FY 2007 Human Tissues budget increase permits FDA to maintain and increase the human tissues goal.  The MDUFMA trigger increase allows an increase in device inspections. 

Performance Highlight: 

FY 2007 Goal Target FY 2005 Results Context
Perform prior notice import security reviews on 60,000 food and animal feed line entries considered to be at high risk for bioterrorism and/or present the potential of a significant health risk.  In FY 2005, FDA exceeded the goal of 38,000 by performing 86,187 prior notice import security reviews. FDA will continue to focus much of its resources on intensive prior notice import security reviews of products that pose the highest potential bioterrorism risks to the U.S. consumer and market.  The Prior Notice Center will receive feedback from import field exams and filer evaluations and begin targeting those individuals that continuously violate the law.  They will also target commodities based on immediate and potential threats to the integrity and security of the intact food supply chain. 

 

Program Resource Changes

 

Budget Authority

Pandemic Preparedness:   + $ 4,031,000 and + 18 FTE

FDA plays a unique and vital role in the Nation's preparedness for an influenza pandemic.  We facilitate the development and availability of safe and effective vaccines and we safeguard America's animal health and food safety systems in the event of an outbreak of avian and pandemic influenza.  FDA is requesting resources for an enhanced and sustained preparedness effort to:

  • Provide extensive outreach and training in manufacturing quality. 
  • Conduct timely and efficient inspections of manufacturing facilities to assure product quality and prevent problems that threaten safety or availability of products essential to respond to the pandemic threat.
  • Issue Custom Alerts to prevent the illegal importation of antivirals into the U.S.
  • Improve FDA's capacity to conduct domestic and import surveillance and respond to reports of food or foodborne illness associated with viruses.
  • Equip field labs and support technology transfer and training of field scientists to ensure adequate capacity to respond to outbreaks of avian influenza. 

Food Defense:  + $17,398,000 and + 4 FTE

The food supply is part of the Nation's critical infrastructure and contributes about 20 percent to the U.S. Gross National Product.  A terrorist attack on the food supply could have catastrophic public health and economic consequences.  The funds requested would continue to enhance laboratory preparedness, food defense research, surveillance, and incident management capabilities.  Through this initiative, FDA will enhance its capacity to prevent, prepare for, respond to and mitigate the effects of a terrorist attack, a major disaster or other emergency on the food supply.  The Field will use the additional resources for the following activities:

  • Expand the FERN system to 16 State laboratories.  Also provide cooperative agreements and technical support to these laboratories and build analytic surge capacity to respond to a terrorist attack.
  • Target potentially high-risk imported foods through Prior Notice Import Security Reviews.  The reviews are based on intelligence, FDA inspection reports, discrepancies in prior notice reporting and sample collection and analysis.
  • Manage the FERN laboratory response for a terrorist attack on (or threat to) the food supply or other food-related emergency.

Human Tissues Safety: + $1,238,000 and + 10 FTE

FDA is implementing a new, risk-based approach to assure the safety of the human cells, tissues, and cellular and tissue-based products (HCT/Ps) involved in these tissue implants.  This initiative will allow FDA to address issues related to safety and effectiveness of a rapidly growing industry.  The current good tissue practice rule became effective May 25, 2005.  This rule requires manufacturers to recover, process, store, label, package and distribute HCT/Ps in a way that prevents the introduction, transmission, or spread of communicable diseases. These rules are critical new tools that give FDA the ability to monitor human tissue adverse reactions to target more effectively the products with the highest risks.  This initiative will fund monitoring and follow-up of adverse events and deviation reports, inspections of HCT/P establishments, and development of guidance and conducting outreach activities.  The human tissue safety initiative is funded at $2.5 million.  The Field portion supporting CBER is $1.238 million and 10 FTE.  FDA is requesting resources to implement the new risk-based comprehensive approach for assuring the safety of HCT/Ps.  The Field will use the additional resources for the following activities.

  • Conduct 75 additional tissue inspections and thereby significantly increase coverage among the approximately 2,000 registered firms.
  • Training of FDA investigators and staff.
  • Compliance activities for manufacturing and processing facilities.

Appropriated User Fee Trigger Needs -- Maintaining Animal Drug Review and Medical Device Review Programs:  + $ 2,049,000 and + 13 FTE 

To meet the statutory requirements for collecting Animal Drug and Medical Device User Fees, FDA must spend a minimum amount of appropriated resources, indexed to the cost of living, on the review process.  If the appropriation and/or spending do not meet these minimum requirements (known as user fee triggers), then the agency is unable to receive the supplemental user fee funding and the programs terminate.  The additional budget authority is needed to ensure that the trigger requirements are met.  The request amount is $7,425,000 and 45 FTE.  For the Medical Device Review Program, the portion for the Center for Devices and Radiological Health is $2.9 million and 15 FTE and the portion for the Office of Regulatory Field is $2.0 million and 13 FTE.

Cost of Living-Pay: + $8,297,000

FDA's request for inflationary pay costs is essential to accomplishing our public health mission.  Payroll costs account for more than sixty-percent of the FDA budget, and the Agency is not able to absorb this level of inflation on such a significant portion of its resources.  The increase will allow FDA to maintain staffing levels, including a national cadre of specially trained scientific staff.  The total estimate for pay increases is $20,267,000. The Field Activities share of this increase is $8.297 million. These resources are vitally important for FDA 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.

Field Activities Reduction[1]:  - $11,442,000 and - 48 FTE

ORA (Field) support the five major program areas regulated by FDA, including Foods, Human Drugs, Biologics, Animal Drugs and Feeds, and Medical Devices.  The Field redeploy base activities in certain program areas in order to support activities under the Agency's high priority initiatives:  Pandemic Preparedness, Food Defense, and Human Tissues Initiatives.  Field reductions include:  the analysis of domestic and import samples of food; the analysis of laboratory samples of human and veterinary drug products; inspection of pre-approval and bioresearch monitoring inspections of veterinary drugs; inspections of veterinary feed manufacturers; inspection of human drugs manufacturers; regulatory research related to the development of laboratory analytical methods for foods, human drug, and animal feed products; compliance and recall functions involving food, human drugs, and animal drugs and feeds; and the management, supervisory, and coordination of personnel at multiple locations involved in the food, human drugs, and animal drug and feeds areas.

 

User Fees

 

Prescription Drug User Fee Act:  +$399,000 and +2 FTE

PDUFA authorized FDA to collect fees from the pharmaceutical industry to augment appropriations spent on drug review.  These fees expand the resources available for the process of reviewing human drug applications including reviewers, information management, space costs, acquisition of fixtures, furniture, equipment and other necessary materials so that safe and effective drug products reach the American public more quickly.  In 2002, the Bioterrorism Act included reauthorization 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 (PDUFA III).  The reauthorization directs 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 increases will contribute to meeting these mandated directives.  In FY 2007 FDA will work with Congress on the reauthorization of the Prescription Drug User Fee Act. This increase of $399,000 will cover inflationary costs, as well as overhead and rent costs, for additional staff associated with the Act. 

Medical Devices User Fee and Modernization Act:  +$101,000 and + 1 FTE

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250, amends the Federal Food, Drug, and Cosmetic Act to provide FDA important new responsibilities, resources, and challenges. MDUFMA was signed into law October 26, 2002 and was amended by the Medical Device User Fee Stabilization Act of 2005. MDUFMA has three particularly significant provisions.  These provisions allow for the collection of user fees for premarket applications, allow establishment inspections to be conducted by third parties and place new regulatory requirements on reprocessed single use devices.  The revenues from these fees, and the appropriated trigger amounts will allow FDA to pursue a set of ambitious performance goals that will provide patients earlier access to safe and effective technology, and will provide more interactive and rapid review to the medical device industry. In FY 2007 FDA will work with Congress on the reauthorization of the Medical Device User Fee and Modernization Act. This increase of $101,000 will cover inflationary costs, as well as overhead and rent costs, for additional staff associated with the Act. 

Mammography Quality Standards Act (MQSA):  +$237,000

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, which was reauthorized in October 2004, addresses the public health need for safe and reliable mammography.  The Act required that mammography facilities be certified by October 1994, and inspected annually to ensure compliance with national quality and safety standards.  The reauthorization codified existing certification practices for mammography facilities and laid the groundwork for further study of key issues that include ways to improve physicians' ability to read mammograms and ways to recruit and retain skilled professionals to provide quality mammograms.  The increase of $237,000 will cover inflation.

 

Proposed User Fees (Reclassified as Mandatory): (Non-Add)

Reinspection User Fee (Mandatory):  + $12,300,000 and + 102 FTE (Non-Add)

The Administration is proposing authorizing legislation that requires establishments to pay the full costs of reinspections and associated follow-up work when FDA reinspects facilities due to failure to meet Good Manufacturing Practices (GMPs) or other important FDA requirements.  Under this proposal, these activities will be reclassified as mandatory user fees in FY 2007.  FDA currently funds this activity through discretionary appropriations.  Imposing a fee would generate $22.0 million in revenue, an estimated amount sufficient to fund the FY 2007 reinspections.  The Field - Office of Regulatory Affairs component of this user fee is $12,300,000 and 102 FTE.

 

Justification of Base

 

In FY 2007, FDA has directed its resources to support the highest risk, highest impact, and highest priority initiatives.  The following activities which are grouped by strategic goal provide more information about FDA's field base activities.  They include noteworthy examples to illustrate base activities.  Activities supporting counter terrorism and food defense appear throughout the following sections. 

 

FDA Strategic Goal:  Improve Product Quality, Safety, and Availability through Better Manufacturing and Product Oversight

 

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

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.

  • Continue to implement regulations issues under the Bioterrorism (BT) Act, such as detaining suspect food when the agency has credible evidence or information that it presents a threat to humans or animals.
  • Strengthen relationships with State partners through the FERN, a national laboratory network that enables FDA to test thousands of food samples within a matter of days if there is a food terrorism event, or a foodborne illness outbreak.
  • Fund FERN state Cooperative Agreements for increased laboratory surge capacity and the National Surveillance Sampling Program.
  • Operate a National Sampling Surveillance Program using FERN to build the capacity to effectively monitor the food supply.
  • Conduct training and proficiency testing of FERN laboratories to assure that these laboratories can achieve consistent testing results.

Electronic Laboratory Exchange Network (eLEXNET) Expansion

eLEXNET has been identified as a candidate system to participate in the National Biosurveillance Integration System (NBIS).  NBIS is being developed by the Department of Homeland Security as a program that will integrate systems that monitor health, environment, and intelligence information across government agencies.  In order to provide food sector-specific information to NBIS, FDA has begun work to develop statistical tools and algorithms for detecting signals that analytes or agents are atypical from normal trends. This activity will enhance eLEXNET's progression toward the achievement of FDA's strategic goal "to improve the  coordination and integration of existing food surveillance capabilities with the Department of Homeland Security's (DHS) integration and analysis function, as part of the government wide Bio-Surveillance Initiative."

 

  • Expand the use of eLEXNET.  It collects lab analytical data on chemical, microbiological, and other contaminants and links federal, state, and other laboratories.  This data capture and exchange system provides the necessary infrastructure for an early-warning system that identifies potentially hazardous foods and enables health officials to assess risks and analyze trends. 
  • Develop effective prevention strategies to "shield" the food supply from terrorist threats, including the capacity for rapid, coordinated responses to a food borne terrorist attack.
  • Intensify the review of products offered for import into the U.S. for safety and security issues.
  • 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 terrorism efforts.
  • Provide training, equipment, facilities, and information technology support to field staff to work on counter terrorism initiatives with a focus on imports.
  • Support the requirements of the Bioterrorism Act of 2002.  This is accomplished by the FDA Unified Registration and Listing System (FURLS) 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.
  • Continue to develop the Food Registration and Prior Notice systems that became operational in the first quarter of FY 2004.
  • Collaborate with CBP to monitor the importation of regulated products and follow-up on the status of products refused entry. Evaluate the accuracy of information import filers provided to the FDA automated entry review system regarding regulated products offered for entry into domestic commerce.
  • Continue to conduct food import exams of food products offered for import into the country.
  • Expand import surveillance at international mail facilities and courier hubs.
  • Continue development of the National Biosurveillance Integration System. The Health Level-7, the departmentally recognized standard for communication in the health arena, was added that will allow eLEXNET to generate standardized messages and use other government recognized terminologies for health and laboratory information.

 

Research, Development, and Evaluation Activities

ORA's research, development, and evaluation activities support the strategic goal through the Method Validation/Development Program.  This program supports the vision of providing a convincing and prevailing scientific and analytical base for regulatory decisions that protect and promote public health.  Vital to carrying out this mission is the development, improvement, and validation of methods that support the agency's regulatory responsibilities.  Specifically, the laboratory techniques developed and validated through the ORA Method Validation/Development Program allow FDA to: (1) evaluate the safety and effectiveness of regulated products; and (2) to detect and respond to threats to public health from foods and medical products. The primary focus of this program is to enhance FDA Center programs through projects in the following two categories.

  • Method Validation: projects designed to evaluate existing methodologies in the regulatory laboratory via peer reviewed assessment and inter-laboratory collaborations.
  • Method Modification, Enhancement, and Extension: projects designed to extend an existing method to one or more additional matrices or analytes; projects designed to improve an existing method.

In coordination and collaboration with FDA Centers, this program also supports projects in the following three categories:

  • Method Development:  Projects designed to develop and implement new methods in the regulatory laboratory.
  • Technology Exploration:  Projects designed to investigate and evaluate the usefulness and applicability of new technologies for the regulatory laboratory and increase our base expertise in these new technologies.
  • Applied Studies:   Projects designed to test hypotheses related to FDA's mission such as food safety, quality mechanisms, contaminants, analyte/matrix interactions, metabolism studies, degradation/depletion studies, and stability studies.

Many ORA research studies aim to apply existing methods to complex and highly varied food commodities.  Examples of these activities include:

  • Validation of methods for the detection of high risk pathogens in food such as Shigella, Escherichia coli, and Clostridium botulinum toxins.
  • Validation of methods to analyze fruits and vegetables for pesticides including evaluation of a faster, more precise carbamate detection method.
  • Rapid Methods for pathogen detection such as Pathatrix, Polymerase Chain Reaction (PCR), and multiplex PCR to increase productivity and decrease sample analysis time in the regulatory laboratory.
  • Methods for improved detection of mycotoxins toxins produced by fungi that grow in grains and produce, often during storage, in a wider variety of food commodities.
  • Methods to detect antibiotic residues in milk and fish intended for human consumption in order to protect against human exposure to antibiotic drugs.

 Examples of food defense research activities include:

  • Method development and validation for the detection of potential bioterrorism agents in food such as Bacillus anthracis, Clostridium botulinum neurotoxin, and Yersinia pestis.
  • Method development and validation for the detection of potential chemical contaminants such as cyanide, ricin, T2 toxin, and radionuclides.
  • In addition to increasing FDA's ability to respond to threats in the food supply, the food defense projects also support activities of the Food Emergency Response Network (FERN).

 

Import Entry Evaluations, Investigations, and Laboratory Analyses 

Since the emergence of the "global marketplace" imported foods have grown increasingly important to the U.S. food supply.  At the current rate of increase, FDA estimates that by FY 2007 the number of imported food lines will have nearly quadrupled since 1999.  This rapid growth combined with ever present security concerns has increased the need to assess the status of imported products.  FDA electronically screens imports through OASIS.  OASIS is an automated system for processing and making admissibility determinations for FDA regulated products that are offered for import.   FDA's electronic screening of imports will be enhanced enhanced by the completion of the Mission Accomplishment and Regulatory Compliance System (MARCS).  Other program objectives include:

  • Review more than 19 million import lines for admissibility into domestic commerce by the end of FY 2007.
  • Expand the use of information on manufacturer, supplier, source country, and past violations to make enhanced admissibility decisions.
  • Continue to perform laboratory analysis on products offered for import into the United States.
  • Continue to conduct inspections of foreign establishments as part of the Foods, Human Drugs, Biologics, Animal Drugs and Feeds, and Devices and Radiological Health programs.

Perform periodic filer evaluations ensure that the data being provided to FDA is accurate.

 

Domestic Inspections and Laboratory Analyses

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.  Related activities include:

  • Identify the food source and contaminant of food borne illness outbreaks ranging from chemical and microbiological to physical hazards.
  • Perform engineering, biological and chemical analysis to prevent the exposure of the public to potentially unsafe or ineffective medical devices, electronic products, radionuclide, and radiopharmaceuticals.
  • Develop laboratory analytical methods to permit the analyses of products for chemical and microbiological hazards.
  • Continue to analyze food samples for pesticides and environmental contaminants.

FY 2005 Domestic Inspections [D]

  • Funding state contracts, partnerships and grants to permit the states to inspect the foods and animal feeds industry; conduct state contract audit inspections to ensure consistent application of regulations during FDA and state inspections of food and animal feed establishments. 
  • Providing criminal investigations of reported product tampering, counterfeit products and other fraudulent criminal activities involving regulated products.

 

Bovine Spongiform Encephalopathy (BSE)

FDA works closely with USDA and State agricultural and veterinary agencies to implement BSE regulations and control imported products that may put the public at risk.  FDA regulates many products that could contain specified risk materials, including vaccines, foods, dietary supplements, 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.  Examples of BSE activities are:

  • Providing Federal and state inspectors with up-to-date information on the BSE feed regulation; the FDA Interim Final Rule on BSE and human food and cosmetics; EU regulatory issues; Animal Plant and Health Inspection Service authority; and, best sampling practices.
  • Leveraging with state agencies by funding contract and cooperative agreement inspections of feed mills and renderers, and conduct compliance, follow-up, and audit inspections to state contracts.
  • Collecting and analyzing domestic and import feed and feed component samples for BSE-related contaminants to ensure proper labeling of animal feeds and feed components.
  • Conducting 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 re-inspected, and other potentially affected firms will be inspected to determine compliance with the regulation.
  • Conducting annual BSE inspections domestically, and review records at U.S. ports of entry of human foods, including dietary supplements and cosmetic manufacturers and processors to confirm compliance with the ban on the use of prohibited material.
  • Conducting a sampling program for animal feeds domestically and those detained at U.S. ports of entry that contain ingredients possibly derived from contaminated animals.

 

Bovine Spongiform Encephalopathy (BSE)

The main focus of the BSE-feed control program has been annual inspections of all renderers and feed mills in the U.S. that process with prohibited material.  FDA continues to find a very high level of compliance with the 1997 rule that prohibits the inclusion of most animal protein in feeds for cattle and other ruminants.  USDA tested more than 500,000 animals and only two animals have been found to be positive.  The most recent positive animal was disposed of by incineration and did not enter into the human food or animal feed chain. 

FDA issued the first BSE cooperative agreements to eight states with a total value of $2 million.  These cooperative agreements are designed to enhance the infrastructure of State BSE control programs.  FDA also plans to expand its inspection activities to lower risk enterprises, such as salvage operations, on-farm mixers and transporters of animal feed.

 

  • Enhancing the ability of our public health system to detect prohibited materials in animal feed, human food, and cosmetics, so FDA will continue to support the development and evaluation of diagnostic tests to identify prohibited materials.
  • Continuing to develop regulations to help prevent the establishment or amplification of BSE in cattle and prevent the potential for development of vCJD in humans.
  • Continuing to develop a real-time PCR (Polymerase Chain Reaction) method that is capable of detecting cattle, swine, sheep, goats, horses, or deer material, along with fowl, to further enhance FDA's ability to detect potentially violative animal feeds.  Part of this effort includes the ability to identify up to three or four different prohibited species in a single reaction.
  • Utilizing validated real-time PCR methodology to identify prohibited animal proteins in rendered materials from non-United States sources as well as materials rendered in the U.S. 

Encourage makers of conventional foods and dietary supplements to make accurate, science-based claims about the health benefits of their products.

 

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.  The Field's role in reducing these injuries and deaths is as follows:

  • Reviewing 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.
  • Conducting investigations of reported errors and product recalls so that program managers can collect information needed to assess the error, and develop error reduction strategies with manufacturers and the medical community.
  • Inspecting hospital device reprocessors to determine compliance with regulatory requirements.
  • Providing training for field staff to improve the information gathered through investigation of consumer complaints and reports of medical errors.

 

Internet Drug Sales

At present, there are an exploding number of new web sites marketing FDA regulated products to the U.S. consumer and medical professionals. FDA currently conducts only minimal levels of web-based oversight. The Office of Criminal Investigations is expanding its efforts to develop cases that address the marketing of counterfeit products. The following is an example of those efforts.

Office of Criminal Investigations:
Drug Safety Activities

  • Approximately 70% of OCI criminal investigative activity is in support of FDA’s Center for Drug Safety Evaluation and Research.
  • These investigations primarily involve counterfeit or unapproved/misbranded drugs, fraudulent drug approval studies, illicit internet drug sales, or tampering.
  • A large percent of these drugs of unknown safety and efficacy are distributed through illicit drug diversion networks.
  • In FY 2005, OCI initiated over 350 criminal investigations, and achieved over 325 arrests, 225 convictions, and over $55,000,000 in fines and restitution.
  • OCI is currently actively investigating the issue of internet and other solicitations for fraudulent medications relating to public concerns about bird flu.
  • In FY2004, FDA’s Office of Criminal Investigations initiated 58 counterfeit drug investigations. OCI’s counterfeit drug investigations typically do not involve inspections.
  • In addition to counterfeit drug cases involving Viagra, Cialis, Lipitor, Celebrex, and Serostim, OCI initiated a growing number of investigations involving illicitly diverted high-cost drugs, such as Zyprexa (an anti-anxiety medication) and Epivir (an AIDS treatment) which has been misbranded by relabeling them to disguise their actual source.
  • OCI has initiated 148 counterfeit drug cases since October 1996.
  • Investigations so far have netted 108 arrests and 58 convictions to date with fines and/or restitution totals in excess of $4,371,675.
  • Monitoring potentially fraudulent Internet sites to identify targets for investigation and sampling of products.
  • Conducting "undercover only" purchases of prescription drugs from Internet sites suspected of engaging in illicit drug sales, distribution, and/or marketing.
  • Providing oversight of mail and courier packages entering the U.S. from foreign sources.

 

FDA Strategic Goal:  Transform FDA Business Operations, Systems, and Infrastructure to Support FDA's Mission in the 21st Century

 

Information Technology

ORA is currently in the midst of a major realignment of its software projects. Burdened with a legacy of stove-piped systems that use outmoded technology, ORA’s automated systems cannot provide the support necessary to ensure that FDA can continue to meet its performance goals. ORA strategy to address this challenge is to combine its IT development efforts into three major programs: Automated Regulatory Management, Data Warehousing and Reporting, and Laboratory Automation. Grouping existing and new IT initiatives into just three areas helps focus resources and management attention on ORA’s growing business needs. It also helps ensure that these programs will work together to capture, maintain, and report the information needed to identify and manage health and safety risks while using scarce resources more effectively.

Automated Regulatory Management: This program encompasses the Mission Accomplishment and Regulatory Compliance System (MARCS).  The MARCS will establish an electronic environment that can dramatically improve the efficiency of FDA field staff.  Benefits include: improved  import screening; management of foreign inspections; tracking of violative products and BSE firms to improve the safety of the food supply; more sharing of information with states; better integration with FDA laboratories; efficient work-load management; the flexibility to address drug importation if required, and the ability to meet the prior notice requirements for 24/7 support.

Data Warehousing and Reporting:  ORA Reporting Analysis and Decision Support System (ORADSS) is a centralized data warehouse that provides integrated decision support to help FDA identify and manage health and safety risks.  This will consolidate ORA's reporting functions.  When fully implemented, ORADSS will be a comprehensive repository of information about FDA regulated facilities and the enterprises that are part of the supply chain for regulated products.  ORADSS' information will allow FDA Centers and management to statistically correlate and analyze multi-year data on geographic areas, firms, products, inspections, and shipments of interest to the FDA. 

The Laboratory Automation: The Laboratory Automation Program, including eLEXNET integration, is an emerging ORA program designed to improve the efficiency of the FDA lab staff the quality of the information the labs provide, and the ability of FDA to share this information with its own centers and other public health labs. In spite of the importance of FDA's labs to critical FDA regulatory activities.  ORA's labs currently depend on manual and semi-automated processes which limit the number and scope of the analyses FDA staff can perform. This program would enable FDA labs to improve chain-of custody tracking, including assignments and sample status; automate collection and processing of analytical data; and track calibration and scheduling to improve the quality of the data produced.  The Lab Automation Program will also integrate with eLEXNET, the network developed jointly by USDA, CDC, and DoD, to communicate unusual findings from laboratory analyses about food-borne pathogens.

 

FDA Strategic Goal:  Increasing Access to Innovative Products and Technologies to Improve Health

 

ORA conducts premarket activities such as bioresearch monitoring of clinical research, preapproval inspections and laboratory method validations needed for application decisions, and inspecting facilities to ensure their ability to manufacture the product to the specifications stated in the application.  Specifically, these activities include:

  • Continuing to develop a program to conduct pre-approval inspections and pre-operational visits in support of the Presidential Emergency Plan for Aids Relief.
  • Conducting bioresearch monitoring inspections to support the drugs, biologics and device pre-approval programs.
  • Supporting the generic drug program through the performance of pre-approval inspections to verify the data submitted in Abbreviated New Drug Applications  and to assess firm's ability to manufacture products in accordance with Current Good Manufacturing Practices).

 

Selected FY 2005 Accomplishments

 

FDA Strategic Goal:  Improving Product Quality, Safety, and Availability through Better Manufacturing and Product Oversight

 

Food Emergency Response Network (FERN)

  • 123 laboratories representing 50 States and Puerto Rico that have satisfactorily completed the FERN Laboratory Qualification Checklist.
  • Awarded eight cooperative agreements to state laboratories to support additional capacity for food analysis related to chemical terrorism and to enhance state, local, and tribal food safety and security efforts.
  • Participated in two FDA surveillance assignments, the Food Security Surveillance Assignment and the Interstate Travel Program Water Assignment.
  • Issued six proficiency test samples including one joint proficiency test sample with CDC/LRN for microbiology laboratory testing of Bacillus anthracis; three chemistry proficiency test samples; and, two radiological proficiency test samples.
  • Conducted five FERN training courses.

 

Food Security Surveillance Assignment

  • Conducted in collaboration with forty-four states and the Commonwealth of Puerto Rico, a Food Security Surveillance Assignment (FSSA) for six weeks.The primary goals of the FSSA were to deter intentional contamination of the food supply through heightened and targeted preventive activities at various points in the food distribution chain and to exercise the systems and networks for responding to a food related emergency during a period of increased food security risk.

 

Laboratory Response to BSE

  • Implemented an advanced analytical procedure for detection of prohibited material in animal feed into an assignment issued for 900 domestic and 900 import feed samples.This novel approach combines light microscopy with polymerase chain reaction (PCR) to determine and detect DNA from ruminants and non-ruminant mammalian species, supporting the BSE/Ruminant Feed Ban.

 

BSE Surveillance

  • Continued collaborative program with our state regulatory counterparts to inspect facilities for compliance with the BSES/ruminant feed ban.

 

Response to BSE Positive

  • Conducted, following the finding of a BSE positive animal in Texas, a feed investigation.  It was joint operation with USDA/APHIS, the Texas Animal Health Commission, and the Texas Feed and Fertilizer Control Service.  FDA accomplished our two main objectives:
    • Identify all protein sources in the animal's feed history that could potentially have been the source of the BSE agent.
    • Verify that cattle leaving the herd after 1997 that were identified by USDA/APHIS as animals of concern (e.g. progeny and feed cohorts), were rendered at facilities in compliance with the BSE/ruminant feed ban regulation.

 

Operation Safeguard Pharmaceutical

  • Conducted with Customs and Border Protection, blitzes of several international mail facilities across the country.  The blitzes revealed substantial numbers of shipments of unapproved drugs, and provided useful information for future targeting efforts.

State Contracts Program

  • Awarded 153 contracts with state and local governments to perform MQSA, feed, tissue residue, food, and medical device inspections. 
  • Implemented electronic State Access to FACTS (eSAF) in 15 state food programs and conducted the associated training for FDA and state personnel.  ORA began designing eSAF to include the feed and BSE programs, which will be piloted in FY 2006. 
  • Conducted auditor training for FDA and state personnel for food and feed contracts. 
  • Completed audits of all state food inspectors working under contract.  
  • Pilot tested an audit program for contracts with New York State.

 

50 State Conference Calls

  • Continued the 50 State Call, which is one of our most effective communication tools to share critical regulatory information with our state counterparts. Calls were held covering such topics as food defense, CDC updates, seafood HACCP, and State legislation on ephedra, BSE rule changes, decorative contact lenses, infant formula, food safety task forces, and dietary supplements.

 

State Grants Program

  • Reviewed and awarded Cooperative Agreement grants for BSE infrastructure improvement in eight states and Food Emergency Response Network (FERN) infrastructure improvement in eight states.
  • Reviewed, renewed, and awarded new grants for Food Safety projects in 34 states and Health Fraud prevention projects in 11 states. 

State Partnership Program

  • Continued to develop new partnerships that have contributed to the exchange of inspection and sampling data and have facilitated the receipt of training and distribution of equipment to the states.
  • Coordinated Partnership Agreements for x-ray inspections in over 20 States. 
  • Conducted BSE and Seafood HACCP inspections under State Partnership.

Risk-Based Screening of Imports

  • Funded a proof-of-concept by the University of New Mexico, completed in May 2005, for an electronic system to use artificial intelligence and extensive data mining to perform risk-based screening of import entries. 
  • Funded, in September 2005, the expansion of that work into a functional prototype which, once operational, could enhance the effectiveness of the import entry review process.

 

Shelf-Life Extension Program

  • Utilized an inter-agency agreement with the Department of Defense to acquire new equipment for the shelf-life extension program.This new equipment not only provided necessary resources for the continuation of the program, but also allowed ORA to broaden the scope of the shelf-life testing to include new products never tested before.

 

MDUFMA Accredited Persons Inspection Program

  • Continued assistance in the Agency's implementation of the Medical Device User Fee and Modernization Act's (MDUFMA) Accredited Persons Inspection Program by providing an FDA inspection course for AP auditors in May 2005.
  • Coordinated, conducted and tracked training in the form of performance audits has been coordinated, conducted and tracked throughout the year.
  • Promoted the program has also been promoted to industry groups in the form of presentations.

Hurricanes Katrina and Rita:
August - September, 2005

The Gulf Coast of the United States, and specifically New Orleans, LA and Gulf Port, MS, have large port operations and are home to major FDA regulated industries, especially seafood harvesting, processing, storage and distribution.There were approximately 1,700 FDA regulated firms in the most heavily storm-impacted counties of Louisiana, Mississippi, Alabama and Florida.To conduct our public health responsibilities in the region, FDA/ORA:

  • Re-established the New Orleans District at the Continuity of Operations site in Nashville, TN and coordinated FDA deployments to assist the CDC teams in Texas to support the evacuee efforts.
  • Worked with the affected states to inspect 417 pharmacies, as well as retail food establishments.In Louisiana alone, FDA contacted 1,461 establishments and assisted 518 retail establishments to reopen, i.e. schools, nursing homes, restaurants, etc.
  • Examined FDA regulated products to assure safety, purity and /or effectiveness; evaluated products to determine whether or not the product was suitable for distribution due to spoilage, contamination, etc.; and, supervised the reconditioning or destruction of those products deemed unsuitable for their original intended use.
  • Provided education outreach materials to assist consumers returning to their homes.
  • The Prior Notice Center provided staff for a 24/7 office coordinated by the USAID Office of Foreign Disaster Assistance (OFDA) Response Management Team set up to receive and distribute foreign-donated humanitarian relief supplies. Fifty-three (53) State Department authorized shipments of FDA-regulated products were identified and reviewed. FDA advised OFDA of decisions regarding the dispensation of the shipments.
  • At the land borders, we worked with local Customs and Border Protection personnel to review and clear non-government donations of humanitarian relief supplies from unofficial sources and non-profits as well as expediting emergency bottled water shipments imported from FEMA contractors so that needed supplies could proceed to destination.

 

Mobile Laboratories

  • Took possession of the completed mobile laboratories in April 2005.Currently, 30 FDA laboratory personnel have been trained in the mobile laboratory platform.
  • Ran a test deployment of the mobile laboratories at NCTR to demonstrate that analysts were able to set up the laboratories on a location site and run sample analyses using only the mobile laboratory facilities.
  • Deployed FDA Mobile Laboratories deployed on Monday October 3rd to Thibodaux, Louisiana in response to the Louisiana Department of Health and Hospitals (LDHH) request for assistance.  LDHH water testing laboratories were completely disabled and unable to perform laboratory testing to assess the quality of shellfish growing waters forcing them to remain closed until water testing resumed.  During the one month deployment, a total of 417 samples were collected and analyzed by a team of FDA and LDHH analysts to assess the fisheries of Lake Pontchartrain and outfall receiving waters of LakDuring the one month deployment, a total of 417 samples were collected and analyzed by a team of FDA and LDHH analysts to assess the fisheries of Lake Pontchartrain and outfall receiving waters of Lake Borgne.  See adjacent picture. 

The data from these analyses has enabled the LDHH to reopen numerous growing areas for the shellfish industry.  This assistance has also allowed the LDHH time to set-up their laboratory facilities so that their staffs were able to return and begin classification of the waters. 

 

Operation Bait and Switch

  • Conducted a multi-district operation to detect import parcels which had been shipped via postal service from a country other than Canada, and which contained pharmaceutical products labeled or identified as coming from a Canadian pharmacy.  FDA found that such products sourced from 39 different countries. 
  • Analyzed a total of 487 samples and found 28 products that were found to be counterfeit (not consistent with authentic product) and one sample significantly sub potent.  In addition, label reviews found some products labeled entirely in a foreign language. 
  • Confirmed, through Operation Bait and Switch, that U.S. consumers have no assurance of quality when purchasing medications from sources outside the normal distribution channels in the U.S. 

 

Tsunami Response 

  • Utilized FDA data and data from the National Geospatial Intelligence Agency to identify approximately 2,600 exporters of foods, drugs, and medical devices in the areas affected. 
  • Demonstrated Prior Notice Center capabilities to target specific imported food commodities for further scrutiny and/or exam as needed to respond to a specific event.  Prior notice targeting criteria were established based on commodity type, previous regulatory history, intelligence, and geographic areas of concern.  A sampling assignment was issued for fresh seafood products that were analyzed for biological hazards and decomposition.

 

FDA Strategic Goal: Enhancing Patient and Consumer Protection and Empowering Them with Better Information about Regulated Products

 

Ephedra-Containing Dietary Supplements

  • Identified more than thirty internet and retail firms selling banned ephedra products
  • Conducted investigations to identify physical locations and other information for regulatory action to uphold the ban on ephedra containing products.

 

Internet Storefront Drugs

  • Obtained a preliminary injunction against one storefront operation facilitating the Internet sale and importation of unapproved prescription drugs from Canada.
  • Coordinated regulatory activities with state regulatory bodies and national regulatory organizations against internet and storefront operations that import unapproved prescription drugs.

 

GlaxoSmithKline, Inc.

  • Announced on April 28, 2005, that GlaxoSmithKline, Inc. had signed a Consent Decree of Condemnation and Permanent Injunction with FDA to correct manufacturing deficiencies at its Cidra, Puerto Rico facility.   FDA was concerned that GSK's violation of manufacturing standards may have resulted in the production of drug products that could potentially pose risks to consumers.

 

Vail Products, Inc.

  • Initiated seizures on March 22, 2005, of all finished Enclosed Bed Systems made by Vail Products, Inc.  This was in a response to ongoing concerns about manufacturing quality and labeling, the FDA and the Department of Justice.  Use of these systems poses a public health risk because patients can become entrapped and suffocate, resulting in severe neurological damage or death.  On August 23, 2005, an order of condemnation and injunction was entered against the seized enclosed bed systems. 

 

ATF Fitness - Dietary Supplement Containing Ephedrine Alkaloids

  • Announced on February 25, 2005, that the Agency had requested the U.S. Attorney's Office for the Western District of Pennsylvania to file a Complaint for Forfeiture against $13,500 worth of adulterated and misbranded dietary supplement containing ephedrine alkaloids that were located at ATF Fitness Products, Inc. in Oakmont, PA. The U.S. Marshals seized the products in response to a warrant issued by the court.  The seizure followed an FDA investigation that determined the products either contained prohibited ephedrine alkaloids or claimed to contain ephedrine or ephedrine alkaloids but did not.

 

Asia MedLabs, Inc. 

  • On November 23, 2004, FDA investigators accompanied the U.S. Marshals Service in a seizure of more than 2.1 million VITERA-XT capsules in the possession of Asia MedLabs, Inc., located in Houston, Texas. Of the total products seized, one million were yet unpackaged capsules; the remainder was contained in more than 14,000 labeled bottles.  The articles were seized because they contained an ephedra-containing dietary supplement marketed by Houston-based Asia MedLabs, Inc. 

 

Pharmakon Labs

  • On July 27, 2005, FDA announced a permanent injunction shutting down operations at Pharmakon Labs of Florida. The company manufactured and distributed cough and cold liquids, tablets and caplets.  Following inspections by FDA and a trial in U.S. District Court, it was determined that drug products sold by Pharmakon Labs, Inc., its president Abelardo L. Acebo, and its secretary/ treasurer Edward R. Jackson (the defendants) did not meet current good manufacturing practice (CGMP) standards and other legal requirements.  The government's request for a permanent injunction was based on the defendants' demonstrated unwillingness to comply with the law.

 

Boston Scientific Agrees to Pay $74 Million to Resolve Allegations of Violations

  • On June 24, 2005, the U.S. Department of Justice announced that Boston Scientific Corporation, Inc., agreed to pay $74 million to the United States to resolve an ongoing investigation concerning its 1998 distribution and subsequent recall of one of its coronary stent delivery systems.  A Civil Complaint was filed in federal district court charging BSC with distributing in interstate commerce 34,589 medical devices that were adulterated and misbranded during August 12, 1998 through October 5, 1998. To resolve the allegations in the civil complaint, BSC, without admitting liability, agreed to pay $74 million to the United States. 

 

FDA Strategic Goal:  Transforming FDA Business Operations, Systems and Infrastructure to Support FDA's Mission in the 21st Century

 

Prior Notice Center (PNC)

  • Began full enforcement of the Prior Notice Interim Final Rule in FY2005, which resulted in the refining of Prior Notice (PN) data targeting criteria and edits to assure the accuracy of the submitted data.The accuracy is critical to help assure that FDA is able to detect and prevent food that may be intentionally contaminated with biological, chemical, or radiological agents, or which may pose significant health risks, from entering the U.S.Thousands of entries were rejected or refused based on inaccurate or incomplete prior notice data submissions, and required resubmission before allowing the subject imported food cargo to transit the U.S.

 

OASIS Import Data System

  • Enhanced the Operational and Administrative System for Import Support (OASIS).  Examples include modifications to improve receipt and processing of prior notice submissions; conversion of the database to ORACLE 9i to support migration from a client application to a direct web application; and modifications to better record the basis for decision-making when releasing or refusing admission to shipments after sampling and analysis, particularly in relation to the risk of bovine spongiform encephalopathy (BSE).  These enhancements will improve system performance, user accountability, and overall productivity for risk-based screening of import entries.

 

ORADSS Upgrades

  • Upgraded its enforcement data warehouse, the ORA Reporting Analysis and Decision Support System (ORADSS) by migration to Business Objects v. 6.5 and by providing extensive training for users.  This will significantly improve the ability of field, ORA headquarters, and Center offices to do in-depth, customized analyses of the effectiveness of compliance programs and enforcement initiatives, and to detect patterns of violations.

 

Mission Accomplishment and Regulatory Compliance System (MARCS)

  • Completed a comprehensive design plan of the MARCS suite of applications.  The plan includes recommendations for the priority and sequence for application rollout, as well as the associated cost and time estimates.  In addition, a Process Control Board was established to validate and prioritize business requirements. 

 

Identity and Trust Management System

  • Implemented the Identity and Trust Management System.  Twelve hundred ORA field inspectors and investigators are now working within a high level of trust assurance.  Using the Turbo EIR application, users are issued digital certificates that protect the confidentiality and integrity of their information.  The system also provides digital signature capability where required. Based on strong ORA compliance advocacy, the certificate authority is maintained and operated at the highest level of assurance. 

 

Electronic Laboratory Exchange Network (eLEXNET)

  • Continued to expand the system.  Of the 113 laboratories in the eLEXNET system, 95 are actively submitting data, an increase of 16 laboratories from the previous year.  The number of FERN laboratories is at 106, an increase of 38, with 60 submitting data, an increase of 26. In addition, the eLEXNET HL7 Implementation Guide was developed which provides exchange of food laboratory analysis data using the HL7 message format.

 

Tactical Work Planner (TWP)

  • Implemented TWP, the first component of MARCS.  The TWP is a Web application providing specialized work assignment support for District managers and staff.  The application provides the ability to view, create, and track the ORA Annual Work Plan and Performance Goals, and also plan, report, and create group assignments that support the compliance program.

 

Electronic State Access to FACTS (eSAF)

  • Expanded the system to include seventeen states that are now trained and using eSAF. The eSAF allows the FDA to expand inspections of facilities by utilizing staff from the state level to enter inspection data directly into FACTS, thus increasing the number of inspections available for review by the agency.  

 

Training

  • Developed and delivered:
    • One course (Advanced non-Clinical BIMO) to 60 students to provide training on emerging issues, new technology and interpreting laboratory data and ECGs that may be reviewed during complex Clinical Bioresearch Monitoring inspections.
    • 43 food related courses to 1,700 state and local regulators to help assure that they have the knowledge and skills to conduct risk based approach inspections.
    • Four BSE related courses to 95 ORA and state regulators in order for them to conduct inspections of animal feed firms; delivered one Microscopic Analysis of Feeds for Processed Animal Proteins course to 20 FDA and state analysts.
    • BSE Inspection training course to state contracted feed control inspectors.
  • FDA employees and state, local and tribal regulators have completed more than 200,000 Web-based training modules.
  • ORA provided FERN training to laboratory analysts to 27 State and 15 FDA employees. 

 

FDA Strategic Goal:  Increasing Access to Innovative Products and Technologies to Improve Health

ORA developed a program to conduct pre-approval inspections and pre-operational visits in support of the Presidential Emergency Plan for Aids Relief.

 

 Combined Field Activities - ORA
Program Activity Data
FOODS FIELD
PROGRAM OUTPUTS-DOMESTIC INSPECTIONS FY 2005 Actual FY2006 Estimate FY2007 Estimate
Domestic Food Safety Program Inspections 4,573 3,400 3,400
Imported and Domestic Cheese Program Inspections 477 400 400
Domestic Low Acid Canned Foods/ Acidified  Foods Inspections 481 400 400
Domestic Fish & Fishery Products (HACCP) Inspections 2,467 2,480 2,480
Import (Seafood Program Including HACCP) Inspections 500 500 500
Juice HACCP Inspection Program (HACCP) 490 375 375
Interstate Travel Sanitation (ITS) Inspections 1,510 1,700 1,700
State Contract Food Safety ( Non HACCP) Inspections 6,992 8,130 8,130
State Contract Domestic Seafood HACCP Inspections 953 1,135 1,135
State Contract Juice HAACP 47 35 35
State Partnership Inspections 1,284 1,300 1,300
Total Above FDA and State Contract Inspections 19,774 19,855 19,855
Total Domestic Reinspections (Non-add) 523 523 523
State Contract and Grant Foods Funding $6,825,000 $7,100,000 $6,940,000
Number of FERN State Laboratories 8 10 16
Annual FERN State Cooperative Agreements/Operations $12,270,000 $7,037,000 $12,236,000
Total State & Annual FERN Funding $19,095,000 $14,137,000 $19,176,000
Domestic Field Exams/Tests 3,528 5,000 5,000
Domestic Laboratory Samples Analyzed 15,390 11,425 9,425
All Foreign Inspections 129 200 100
Total Foreign Reinspections (Non-add) 15 15 15
Import Field Exams/Tests 84,997 75,000 71,000
Import Laboratory Samples Analyzed 25,549 31,600 29,600
Import Physical Exam Subtotal 110,546 106,600 100,600
Import Line Decisions 8,672,168 10,059,715 11,669,269
Percent of Import Lines Physically Examined 1.27% 1.06% 0.86%
Prior Notice Security Import Reviews
 
 
 
(Bioterrorism Act mandate) 86,187 45,000 60,000

 

COSMETICS FIELD
PROGRAM OUTPUTS-DOMESTIC INSPECTIONS FY 2005 Actual FY2006 Estimate FY2007 Estimate
All Inspections 138 100 100
Total Domestic Reinspections (Non-add ) 7 7 7

PROGRAM OUTPUTS-IMPORT/FOREIGN INSPECTIONS

 
Import Field Exams/Tests 1,983 2,000 2,000
Import Laboratory Samples Analyzed 241 200 200
Import Physical Exam Subtotal 2,224 2,200 2,200
Import Line Decisions 1,146,049 1,398,180 1,705,779
Percent of Import Lines Physically Examined 0.19% 0.16% 0.13%

 

DRUGS FIELD
PROGRAM OUTPUTS-DOMESTIC INSPECTIONS FY 2005 Actual FY2006 Estimate FY2007 Estimate
Pre-Approval Inspections (NDA) 149 130 130
Pre-Approval Inspections (ANDA) 81 135 135
Bioresearch Monitoring Program Inspections 562 520 520
Drug Processing (GMP) Program Inspections 1,365 1,500 1,440
Compressed Medical Gas Manufacturers Inspections 125 155 150
Adverse Drug Events Project Inspections 106 135 135
OTC Monograph Project Inspections and 11
 
 
Health Fraud Project Inspections 1 53 45 45
State Partnership Inspections: Compressed Medical Gas Manufacturers Inspections 85 110 110
State Partnership Inspections: GMP Inspections 57 50 50
Total Above FDA and State Partnership Inspections 2,594 2,780 2,715
Total Domestic Reinspections (Non-add) 220 220 220
Domestic Laboratory Samples Analyzed 1,446 1,735 1,600

PROGRAM OUTPUTS- IMPORT/FOREIGN INSPECTIONS

 
Foreign Pre-Approval Inspections (NDA) 163 180 180
Foreign Pre-Approval Inspections (ANDA) 77 60 60
Foreign Bioresearch Monitoring Program Inspections 85 65 65
Foreign Drug Processing (GMP) Program Inspections 217 195 195
Foreign Adverse Drug Events Project Inspections 10 25 25
Total Above Foreign FDA Inspections 552 525 525
Total Foreign Reinspections (Non-add) 17 17 17
Import Field Exams/Tests 4,288 4,400 4,400
Import Laboratory Samples Analyzed 1,045 355 300
Import Physical Exam Subtotal 4,850 4,850 4,700
Import Line Decisions 264,559 317,471 380,965
Percent of Import Lines Physically Examined 1.83% 1.53% 1.23%
Note:
1. The OTC Monograph and Health Fraud Inspections will no longer be planned separately in FY 2006.

 

BIOLOGICS FIELD
PROGRAM OUTPUTS-DOMESTIC INSPECTIONS FY 2005 Actual FY 2006 Estimate FY2007 Estimate
Bioresearch Monitoring Program Inspections 121 156 156
Blood Bank Inspections 1,439 1,130 1,070
Source Plasma Inspections 188 165 160
Pre-License, Pre-Approval (Pre-Market) Inspections 3 10 10
GMP Inspections 42 36 36
GMP (Device) Inspections 14 35 35
Human Tissue Inspections 270 250 325
Total Above Domestic Inspections 2,077 1,782 1,792
Total Domestic Reinspections (Non-add) 50 50 50
PROGRAM OUTPUTS- IMPORT/FOREIGN INSPECTIONS  
Blood Bank Inspections 16 24 24
Pre-License Inspections 6 0 0
GMP Inspections 15 24 17
Total Above Foreign FDA Inspections 35 43 41
Total Foreign Reinspections (Non-add) 4 4 4
Import Field Exams/Tests 1 143 100 100
Import Line Decisions 39,979 44,377 49,258
Percent of Import Lines Physically Examined 0.36% 0.23% 0.20%

 

ANIMAL DRUGS & FEEDS FIELD
PROGRAM OUTPUTS-DOMESTIC INSPECTIONS FY 2005 Actual FY2006 Estimate FY2007 Estimate
Pre-Approval /BIMO Inspections 72 140 110
Drug Process and New ADF Program Inspections 230 210 210
BSE Inspections 3,025 3,760 3,760
Feed Contaminant Inspections 13 15 15
Illegal Tissue Residue Program Inspections 203 245 245
Feed Manufacturing Program Inspections 369 240 40
State Contract Inspections: BSE 3,309 4,562 4,562
State Contract Inspections: Feed Manufacturers 457 347 347
State Contract Inspections: Illegal Tissue Residue 370 750 600
State Partnership Inspections: BSE and Other 988 900 900
Total Above FDA and State Contract Inspections 9,036 11,169 10,789
Total Domestic Reinspections (Non-add) 173 173 173
State Animal Drugs/Feeds Funding $1,300,000 $1,700,600 $1,800,000
BSE Grant Increase $3,000,000 $3,000,000 $3,000,000
State Contract for Tissue Residue $220,000 $220,000 $210,000
Total State Funding $4,520,000 $4,920,600 $5,010,000
Domestic Laboratory Samples Analyzed 1,841 1,770 1,730

PROGRAM OUTPUTS-IMPORT/FOREIGN INSPECTIONS

 
Foreign Pre-Approval/Bioresearch Monitoring Program Inspections 26 45 45
Foreign Drug Processing and New ADF Program Inspections 12 10 10
Total Above Foreign FDA Inspections 38 55 55
Total Foreign Reinspections (Non-add) 3 3 3
Import Field Exams/Tests 4,298 4,500 4,500
Import Laboratory Samples Analyzed 753 1,120 900
Import Physical Exam Subtotal 5,051 5,620 5,400
Import Line Decisions 212,254 235,602 261,518
Percent of Import Lines Physically Examined 2.38% 2.39% 2.06%

 

DEVICES FIELD
PROGRAM OUTPUTS-DOMESTIC INSPECTIONS FY 2005 Actual FY 2006 Estimate FY2007 Estimate
Bioresearch Monitoring Program Inspections 329 300 300
Pre-Approval Inspections 64 130 130
Post-Market Audit Inspections 63 65 65
GMP Inspections (Levels I, II, III and Accredited Persons) 1,430 1,530 1,530
Total Above Domestic Inspections: Non MQSA 1,886 2,025 2,025
Inspections (MQSA) FDA Domestic (non-VHA) 366 335 371
Inspections (MQSA) FDA Domestic (VHA) 32 32 32
Inspections (MQSA) by State Contract 8,340 7,924 7,700
Inspections (MQSA) by State non-Contract 545 530 530
Total Above Domestic Inspections: MQSA 9,283 8,821 8,633
Total Domestic Reinspections (Non-add) 237 237 237
State Contract Devices Funding $1,350,000 $250,000 $275,000
State Contract Mammography Funding $9,800,000 $9,200,000 $9,940,000
Total State Funding $11,150,000 $9,450,000 $10,215,000
Domestic Radiological Health Inspections 107 130 130
Domestic Field Exams/Tests 944 1,215 1,215
Domestic Laboratory Samples Analyzed 200 217 217

PROGRAM OUTPUTS-IMPORT/FOREIGN INSPECTIONS

 
Foreign Bioresearch Monitoring Inspections 6 10 10
Foreign Pre-Approval Inspections 17 34 34
Foreign Post-Market Audit Inspections 26 27 27
Foreign GMP Inspections 225 207 189
Foreign MQSA Inspections 16 15 15
Foreign Radiological Health Inspections 9 19 19
Total Above Foreign FDA Inspections 299 312 294
Total Foreign Reinspections (Non-add) 24 24 24
Import Field Exams/Tests 6,901 5,000 5,000
Import Laboratory Samples Analyzed 1,333 1,440 1,440
Import Physical Exam Subtotal 8,234 6,440 6,440
Import Line Decisions 3,484,393 4,460,023 5,708,829
Percent of Import Lines Physically Examined 0.24% 0.14% 0.11%

 


[1] The amount shown in the Strategic Redeployment paragraph is shown for illustrative purposes.  The Foods, Human Drugs, Biologics, Animal Drugs and Feeds, and Devices and Radiological Health programs include the Office of Regulatory Affairs - Field Activities portion in the Strategic Redeployment paragraphs of these programs.

 

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