U.S. Food and Drug Administration
Performance Plan
2002

2.5 ANIMAL DRUGS AND FEEDS

2.5.1 Program Description, Context, and Summary of Performance

Total Program Resources:

The mission of the Animal Drugs and Feeds Program is to protect the health and safety of all food producing, companion or other non-food animals; and, to assure that food from animals is safe for human consumption. To support this mission, the Center for Veterinary Medicine (CVM) focuses on two strategic goals:

1. Increase the availability and diversity of safe and effective animal drugs and feeds.
2. Reduce the risks associated with marketed animal products.

These strategic goals reflect CVM's involvement in the animal drug development process from the point at which the drugs are first developed through the time they are on the market. This coverage of the entire drug development process enables CVM to address problems or safety issues before they become a threat to public health. CVM accomplishes these goals by working with partners in industry, academia, consumers, and other government agencies. The premarket program is using several initiatives to expedite the animal drug review process including pre-submission conferences, development of electronic submissions, and the revision and development of guidance documents. On the postmarket side, CVM compliance inspection and surveillance monitoring activities manage public health risks such as Bovine Spongiform Encephalopathy (BSE) and antibiotic resistance. CVM's approach to achieving the strategic goals and summary of the key performance goals are explained in the following sections.

2.5.2 Strategic Goals

Strategic Goal 1:
Increase the availability and diversity of safe and effective animal drugs and feeds.

A. Strategic Goal Explanation

Veterinarians and the agricultural community need animal drugs to ensure a safe food supply and to ensure the health of companion animals. The availability of safe and effective drugs allows food animal producers to maintain healthy animals with assurance the resulting products will be safe, wholesome, and free of drug residue when they reach the consumer. Also, the availability of safe and effective drugs ensures companion and guide animals (used to assist individuals with disabilities) live healthier and longer lives.

CVM promotes the availability and diversity of animal drugs and feeds by being involved throughout the new animal drug approval process. CVM reduces overall developmental costs of these products by working with industry sponsors. CVM's practice of "Phased Review" provides industry sponsors with timely feedback on product applications, and may detect application deficiencies early in the drug approval process. Pre-submission conferences (Performance Goal 1) and guidance documents (Performance Goal 5) increase industry efficiency. The Agency is committed to improving the review time for new animal drug applications (NADAs) (Performance Goal 2). Development of an enhanced information system for electronic submission of applications and data will allow FDA to perform application review activities more efficiently (Performance Goal 3). To ensure that FDA has the science capability and intellectual capital necessary to assess data and make regulatory decisions, a staff college is being developed (Performance Goal 5). Risk assessment models will evaluate the risk to human health from resistant foodborne pathogens associated with consumption of antimicrobials in food producing animals (Performance Goal 7).

These premarket performance goals help the Agency take the specific steps needed to achieve this strategic goal. When the "reinvented review process" is running efficiently and effectively, it will produce outcomes that matter to the U.S. taxpayer: reduce human mortality and morbidity rates by assuring safer animal products; reduce the cost and time associated with animal drug development; and, improve quality of life for segments of our population because companion animals are healthier and live longer.

B. Summary of Performance Goals

C. Goal-by-Goal Presentation of Performance

1. Maintain the level of requested pre-submission conferences conducted with industry sponsors at 80%. (14007)

• Context of Goal: The Animal Drugs and Feeds Program informs and assists product sponsors throughout the approval process starting with the pre-submission conference. The focus is to inform and assist firms in complying with the new legislation and to streamline the product review process through phased review. Instead of waiting until all stages of product development are completed before contacting FDA, phased review helps industry stay on course throughout the drug development process by communicating requirements (or standards or criteria) for approval at each stage of development.
• Data Sources: Submission Tracking and Review System (STARS).
• Performance: Presubmission conference tracking was established in FY 99. The goal was met for FY 00 and FY 01. Based on current data, 80% is a reasonable target for FY 02 and FY 03.

2. Review and act on 90% of all new animal drug applications and supplements within 275 days and review and act on 90% of all investigational new animal drug data submissions (type P) within 325 days. (14017)

• Context of Goal: In FY 03, CVM is changing this performance goal to a new measure that is a more useful for both Center management and industry. Key industry stakeholders have told us that 'how long an application takes to get reviewed' is more meaningful to them than 'what percent is reviewed on time'. CVM has also introduced a new performance goal (Goal 3) to emphasize its commitment to reducing the current backlog in applications. FDA is taking steps to move closer to statutory requirements in future years.
• Data Sources: Submission Tracking and Review System (STARS).
• Performance: The performance reporting for FY 99 through FY 02 pertains to the review and action on NADAs and ANADAs within 180 days of receipt. In FY 99, CVM updated its tracking system to be consistent with procedures under ADAA achieving a 73% performance rate. CVM slightly exceeded the FY 00 target with a performance rate of 75%. In FY 2001, CVM reviewed and acted on approximately 50% of New Animal Drug applications (NADAs) and Abbreviated New Animal Drug Applications (ANADAs) within 180 days of receipt.
  CVM found it necessary to shift focus in its performance regarding animal drug application review in FY 2001. The Office of New Animal Drug Evaluation (ONADE) needed to reduce the backlog of overdue documents. This required working on the oldest, already overdue documents. Decreasing the backlog was necessary in order to move CVM back on track towards meeting statutory and stakeholder requirements for new animal drug application review. By taking the step of closing out the most overdue documents, CVM's on time completion rate for NADAs and ANADAs was adversely affected this year. Although approximately 50% of NADAs and ANADAs were reviewed on time in FY 2001, CVM reduced its backlog of pending overdue documents by 1,334, from 2,234 to 900.
  The goal for FY 02 has been revised to review and act on 50% of NADAs/ANADAs within 180 days of receipt. The goal was revised from 80% to 50% because the Center has changed priorities and redirected resources to clear the large backlog of animal drug applications.

3. Reduce pending overdue Animal Drug Applications by 15%. (14019)

• Context of Goal: During FY 2001, the Center conducted an evaluation of our performance in the new animal drug review process and determined that our priorities needed to shift in order to eliminate the backlog in pending new animal drug submissions. This goal was created for FY 02 and FY 03 to facilitate that process and to provide the needed emphasis on this strategic goal of making more animal drugs available.
• Data Sources: Submission Tracking and Review System (STARS).
• Performance: The Animal Drugs and Feeds program will reduce the backlog of pending overdue animal drug applications by 15% in both FY 02 and FY 03.

4. Continue to pilot and validate procedures to receive protocol submissions electronically. (14002)

• Context of Goal: We have initiated processes to obtain input from our stakeholders in order to develop meaningful performance measures to assess progress consistent with reinvention initiatives. Better-automated information systems, including those supporting electronic submission of applications by sponsors, are being developed to facilitate and expedite the review process. CVM has successfully completed several electronic submission processes for use by the animal industry. Our intention is to move toward the paperless office as rapidly as possible. Some changes in regulations will be required before we can implement electronic process for all types and phases of submission.
• Data Sources: CVM's priority project tracking system.
• Performance: In FY 99, the Animal Drugs and Feeds Program completed implementing the electronic submission process for all Notices of Claimed Investigational Exemptions (NCIE) submissions. An evaluation indicated processing time was reduced to 1/3 the time required for paper processing. In FY 00, CVM published Federal Register Notices on four (4) draft guidance documents pertaining to electronic submissions.
  In FY 01, all sponsors receiving instructions on submissions are advised of the availability of using the e-mail method for some submissions and directed to our website for instructions. A workshop was held to highlight new and improved systems and forms available for electronic information transfer. System modifications made smart form available to increase quality control of information input by submitters, and automated login to the Center's tracking system and forwarding for review.
  Use of the Center's email to submit electronic information expanded to 15 sponsors from 13. Currently available forms and types of submissions on the Agency's Electronic submission docket: Notices of Claimed Investigational Exemptions; Notice of Intent to Slaughter for Human Food Purposes; Notice of Final Disposition of Animals Not Intended for Immediate Slaughter; and Request for a Meeting or Teleconference. These are all supported by guidance documents and smart forms released February 2001. Information is available through our web page.
  Protocal Submissions: CVM has delayed electronic receipt of Protocol Submissions until automation requirements of a more complicated business review process have been fully developed.
  In July, 2001, CVM increased the automation of the NCIE, Intent to Slaughter, Notice of Final Disposition, and Meeting Request by providing the sponsors with a PDF fill-in form for submission by e-mail, allowing a higher degree of automated processing at CVM by uploading data in the STARS tracking database. The time required for verification of receipt to the sponsor has been decreased to a few minutes from a potential high of three days. In 2001, the Center posted a reference on the electronic dockets that allows submission of data in electronic format in support of New Animal Drug Applications. This allows interested parties, with the concurrence of the Center to submit more extensive data electronically. The Center is working toward a draft of CVM-specific guidance for file organization and format for hard media submissions. The Center is also expanding its current electronic archive to accept hard media submissions. The Center has also become active in coordinating the Agency effort to harmonize standards in the Agency, and has participated in the Agency-wide General Consideration Document that will publish for comment early in 2002. CVM will participate in the Agency guidance and acceptance of submission to the Agency of Manufacturing Stability data in XML format. The Center will also participate in an Agency Panel at the Drug Information Association Meetings in February 2002. Work has also begun on the guidance and smart form design for the submission of Adverse Drug Experience reports - both by form and XML data sets. Additional phases of electronic submissions will be initiated in FY 02 and FY 03 in support of this goal.

5. Begin to design and implement a Staff College in CVM to increase and maintain the scientific expertise in the Center. (14018)

• Context of Goal: Staff College programs have been developed in FDA as a means of continuously building the scientific and intellectual capability of its staff. The addition of a CVM Staff College will allow CVM to increase and maintain a level of scientific expertise that is critical in order for us to address evolving animal science and veterinary medicine issues. The Staff College will use funds to outsource the planning and implementation of training programs tailored to the needs of in-house scientists.
• Data Sources: CVM's priority project tracking system.
• Performance: FY 99: Identify need to enhance and maintain scientific expertise. FY 00: Develop a strategy to establish a Staff College in CVM. FY 01: Initiated Phase I - conduct further needs assessment, feasibility studies, and analysis of alternatives:
  • Contract awarded to perform needs assessment and begin building the Staff College infrastructure necessary for a competency based learning management system to enhance the science-base.
  • Began the research and design of a training facility to support the infrastructure of the CVM Staff College. Awarded a facilities and equipment contract and construction of the training facility began late in FY01.
  • Recruited a FDA/CVM Search Team to conduct a nationwide search for a qualified Staff College Director who could continue building the Staff College infrastructure. Review of the 130 candidates was completed late in FY 01.
  • Conducted in-house development and implementation of seminars, professional meetings and courses that increased the science-based knowledge of the FDA's review staff which can help reduce review times and backlogs of pending applications.

6. Revise and develop 14 guidances for the regulated veterinary industry. (14001)

• Context of Goal: Reform legislation and reinvention initiatives, such as the Results Act (RA) and FDAMA, require input from our customers and stakeholders. Input from customer surveys, stakeholder meetings, and other interactions with regulated industry helped FDA target resources toward developing guidance documents that will accurately reflect the current veterinary medicated feed and drug approval/monitoring processes. Guidance documents reflect changes in the approval processes resulting from enactment of the ADAA, FDAMA, and CVM's efforts to reinvent its new animal drug approval processes. The availability of guidance documents facilitates accurate and complete preparation of drug applications. Development of new guidance documents and updating existing documents to reflect recent changes in legislation were initiated in FY 99 and will continue into FY 00 and FY 01. FDA has identified an estimated 14 guidances to be developed or revised according to projected availability of resources and analyses of the complexity of the material. (Goal dropped for FY 2002.)
• Data Sources: CVM's priority project tracking system.
• Performance: The original FY 99 target was to perform an initial review of the 77 guidance documents and to initiate revisions or develop new guidance documents as appropriate. In FY 99, we intended to revise or develop "at least" one document (1% of the existing documents). Our goal was exceeded. The staff wrote 8 guidance documents: 3 FDAMA and 5 VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). One of the FDAMA guidances is related to dispute resolution and another to supplemental applications. In FY 00, CVM published 19 draft and/or final guidances (including 7 VICH documents). In FY 01, 14 draft and/or final guidances were completed: 3 manufacturing, 10 new animal drug approval process, and 1 VICH.
  This goal is dropped in FY 02 since CVM can not directly measure the number of (increased) drug approvals tied to the revision/development of guidance documents. Guidance documents improve the efficiency of phased review (applications are submitted with complete forms that contain required information); however, the number of submissions from industry will not necessarily increase due to issuance of guidance documents.

7. Develop an antibiotic risk assessment model using Fluoroquinolone as the antibiotic, chickens as the animal species and Campylobacter as the bacterial isolate. (14003)

• Context of Goal: Improved risk assessments will provide tools that will allow CVM to evaluate the public health risks associated with using antimicrobial products in food producing animals. Risk assessment provides a strong foundation upon which efficient allocation of scarce food safety resources can be made. Furthermore, risk assessment often plays a central role in the development of any science-based system of preventive controls. (Goal dropped for FY 2002.)
• Data Sources: The NARMS database mentioned later in this report, surveillance systems of other government organizations (e.g. CDC and USDA), and published literature.
• Performance: The Center has used the principles of risk assessment to determine that the microbial safety of antibiotics used in food animals be assessed prior to approval. The assessment modeled the risk of having a resistant Campylobacter infection attributable to the use of fluoroquinolones in chickens and being treated with a fluoroquinolone. The draft risk assessment report on Campylobacter was made available on the CVM homepage and was discussed at a workshop held December 9-10, 1999. The final document was released in October 2000. Based partly on the results of the Campylobacter risk assessment, CVM proposed to withdraw approval of the new animal drug application for use of the fluoroquinolone antimicrobial drug enrofloxacin in poultry. One of the two sponsors, Abbott has voluntary withdrawn the product. Bayer is requesting a hearing. If the approval is withdrawn, this drug would no longer be legally marketed for this indication. Other approved uses of fluoroquinolones in cattle, dogs, and cats are not affected by this proposal.
  On April 5, 2001, FDA/CVM announced that a feasibility study had been completed for a risk assessment on the link between the use of virginiamycin in animals and Synercid™ resistance in humans. Based on the feasibility study, the Center for Veterinary Medicine determined that sufficient data did exist or was forthcoming to support a quantitative risk assessment of the human health impact from the use of virginiamycin in food-producing animals. Unlike the Campylobacter risk assessment where the transfer of resistance is direct through the consumption of products contaminated with resistant Campylobacter, this second assessment will model the indirect transfer of resistance.
  This goal was dropped for FY 02 because the risk assessment on fluoroquinolone resistance in Campylobacter has been completed.

Strategic Goal 2:
Reduce the risks associated with marketed animal products.

A. Strategic Goal Explanation

Once animal drugs are on the market, CVM continues managing public health risks through activities such as inspections and antimicrobial resistance monitoring. These CVM strategies for assuring safety compliance and scientific monitoring are made possible through partnerships with industry and the states. Surveillance of marketed products and the business industry is accomplished through review of drug experience reports and compliance programs. This involves inspections, sample collections and analysis, investigations, and other activities (Performance Goals 8 and 9). Regulatory actions are taken as needed to control violative goods and firms.

CVM surveillance systems identify potential human and/or animal health hazards. The surveillance systems also help develop procedures and strategies to prevent, minimize, or contain problems (such as informing the veterinary community of adverse reactions due to drug interactions that were not apparent in clinical trials or withdraw marketed drugs as necessary to protect human and animal health). The desired outcome is to assure that marketed animal drugs and food additives provide safe food products derived from animals and ensure quality health care of animals.

The National Antimicrobial Resistance Monitoring System (NARMS), part of the President's Food Safety Initiative, was developed to provide an effective early-warning system that can detect food illness outbreaks early and prevent their spread. NARMS (Performance Goal 10), developed in conjunction with USDA and CDC, has greatly improved our ability to detect emerging antibiotic resistance among foodborne pathogens. This helps ensure the continued effectiveness of both human and veterinary drugs and aids in increasing the availability of effective drugs for treatment of foodborne disease. This system also advances understanding of foodborne illness and prevention efforts.

Another critical FDA goal is to prevent the introduction and spread of Bovine Spongiform Encephalopathy (BSE) into the U.S. herd and human food chain. There is strong scientific evidence (epidemiological and laboratory) that the agent that causes BSE in cattle is the agent that causes variant Creutzfeldt-Jakob Disease (vCJD) in people. If BSE emerged in the U.S. it could pose a serious health risk to humans and be financially devastating to the U.S. beef industry. CVM plans to conduct 100% inspections of all known renderers, FDA licensed and non-licensed feed mills in order to maintain compliance with the BSE feed regulation. (Performance Goal 11).

B. Summary of Performance Goals

C. Goal by Goal Presentation of Performance

8. Maintain biennial inspection coverage by inspecting 50% of registered animal drug and feed establishments. (14009)

• Context of Goal: FDA exercises considerable discretion regarding the frequency and comprehensiveness of inspections. FDA has a statutory obligation to inspect all regulated animal drug and medicated feed establishments once every two years. In response to public demand for increased drug availability, FDA continues to emphasize postmarket monitoring. Routine inspections have lower priority than inspection of firms producing high profile products. This has an impact on the pre-approval process that requires a "recent" inspection before approval of a new animal drug. This includes inspections done by FDA directly, or through state contracts or partnership agreements on manufacturers, repackers and relabelers (drugs), and manufacturers and growers requiring a Medicated Feed Mill License. In FY 1999, there were 1,418 registered establishments. The increase in the inspection coverage target from 27 percent to 50 percent in FY 2001 through FY 2003 is attributed to the ability to hire up to the number of inspectors to assist toward accomplishment of this goal.
• Data Sources: Field Accomplishment Compliance Tracking System (FACTS) [formerly known as the Program Oriented Data System (PODS)], Official Establishment Inventory.
• Performance: FY 99 = 25%; FY 00 = 39%; FY 01 = 37%. In FY 99, 25% of registered animal drug and feed establishments were inspected. The FY 99 actual performance fell short of the 27% target based on the fact that the initial inspection percentages were estimates, due to the complexity and number of inspections, and re-inspections.
  In FY 00, FDA inspected 39% of the establishments in the Official Establishment Inventory, exceeding the goal of 27%. Due to a few problems resulting from the transition to a new database (FIS to FACTS) in FY 2000, some adjustments in counting the inventory and inspectional coverage were necessary. It is expected that any inconsistencies will be corrected when the FY 2001 performance is reported. The goal was not met in FY 2001. The program did accomplish 37% biennial inspection coverage of registered animal drug and feed establishments. The need to perform BSE inspections became a higher priority in FY 2001 because of the increase in reported cases of BSE in Europe. To minimize the risk of BSE introduction into US cattle herds and to protect the health of American citizens, the program received contingency funding. After re-establishing priorities within the field portion of the Animal Drugs and Feeds Program, BSE inspections were instituted to ensure that 100 percent of renderers, protein blenders, and feed mills were inspected; and to conduct sample analysis to assure compliance with the BSE regulation. The BSE crisis in England and Europe made it apparent that 100 percent of renderers, protein handlers, and feed mills handling prohibited material would need to be inspected every year to continue to protect US cattle herds from BSE and the health of American citizens.

9. Assure that FDA inspections of domestic animal drug and feed manufacturing establishments and repackers, in conjunction with the timely correction of serious deficiencies identified in these inspections, result in at least 90% conformance with FDA requirements. (14004)

• Context of Goal: (Goal dropped for FY 02 and 03) In previous FDA performance plans, goals were established for maintaining the level of industry conformance to FDA requirements at 90% or above for each of the Agency product-oriented programs. This year we are recommending that these goals be deleted from the Plan. This is our rationale: Inspections are the Agency's method for determining whether an establishment is in or out of compliance with FDA requirements. Because of resource constraints, the Agency must allocate a significant proportion of its inspections to high risk situations, such as food firms who are producing high risk foods, or to emergency situations such as BSE. The number of remaining inspections each year is not adequate to draw a statistically valid inference about the compliance status of an entire industry at a reasonably high level of confidence. It is the Agency's professional judgement that the majority of firms in the regulated industries are in conformance with FDA's requirements. Based on the Agency's experience over several years, that percentage in general, has remained at 90% or above. Thus, establishing a performance goal that simply describes the stable state of the industry does not provide useful new information; nor does it serve as a management tool to drive the overall industry to a higher level of conformance.
• Data Sources: FDA Field Data Systems.
• Performance: FY 97 = 97%; FY 98 = 98%; FY 99 = 99%; FY 00 = 97%; FY 01 = 99%. The conformance rates are based on a statistical modeling from actual inspection and serious deficiency (Official Action Indicated) data. The rates are representative of the firms inspected in a given year. As the statistical model and industry coverage is improved, the rates will better represent the conformance status of the overall industry.

10. Maintain isolate testing rate for Salmonella in National Antimicrobial Resistance Monitoring System (NARMS) at 12,000 for human and animal isolates. (14005)

• Context of Goal: NARMS was initiated in 1996 as a major national surveillance effort of CVM's Food Safety Initiative (FSI) in cooperation with FDA, CDC, and USDA. NARMS detects emerging antibiotic resistance among foodborne pathogens and the possible associated health hazards through systematic collection, analysis and interpretation of antimicrobial susceptibility surveillance data. In addition, the program data help to justify educational efforts and prudent drug use campaigns in humans and in veterinary medicine. NARMS is adding to our knowledge of drug susceptibility and is helping ensure the continued effectiveness of human and veterinary drugs.
• Data Sources: National Antimicrobial Resistance Monitoring System.
• Performance: In FY 99 = collected 8,510 animal and 1,706 human isolates; FY 00 = collected 9000 animal and 2000 human isolates. We will increase the goal to 12,000 isolates per year for 2001-2003, which we will continue to send for serotyping, susceptibility testing, and quality control testing. Reports will continue to be generated and analyzed.
  The performance data for FY 01 will not be available until March 2002.

NARMS Success Stories:

NARMS was established in January 1996 as a collaborative effort among the FDA, USDA, and CDC. Funding was used to expand the scope of the monitoring system and conduct follow-on research and investigations. The system now tests non typhoid Salmonella, Campylobacter, Enterococcus and E. coli isolates collected from animal sources, and non typhoid Salmonella, Campylobacter, Enterococcus, Shigella, Salmonella typhi and E. coli isolates from human clinical samples. In addition, new sites and sources of isolates have been added. NARMS data has been used to initiate field investigations of outbreaks of illness marked by a pathogen which displayed an unusual antimicrobial resistance pattern, assess the human health impact of fluoroquinolone use in poultry, stimulate research in molecular characteristics of resistance emergence and transfer, improved our knowledge of risk factors associated with the development of an antimicrobial-resistant infection, and has triggered broader research projects of prudent antimicrobial use in animals and the role of the environment in the emergency and spread of antimicrobial resistance.

NARMS was also expanded into the international arena during FY 2000. A pilot study was conducted with medical microbiologists from hospitals in three states in Mexico that have significant animal agriculture in close proximity to the hospitals. The pilot study consisted of initial training of the investigators at the USDA Russell Research Center (in Athens, Georgia) in standardized laboratory methodologies for the isolation, identification, and antimicrobial susceptibility testing of foodborne Salmonella. Sample collection and isolation of Salmonella took place from clinically ill humans in the Mexican hospitals and from healthy children in community daycare centers. This collaboration between U.S. NARMS officials and the Mexican antimicrobial surveillance group represents the beginning of the first international human and animal monitoring system for foodborne antimicrobial drug susceptibility surveillance in the Americas.

11. Conduct targeted BSE inspections of 100% of all known renderers and feed mills handling prohibited material. (14006)

• Context of Goal: CVM sought to protect the public through the development of a comprehensive strategy of education, inspection and enforcement action on industry. These activities were initiated to ensure compliance with the Bovine Spongiform Encephalopathy (BSE) regulations. Using an inventory of all known renderers and FDA licensed and non-licensed feed mills, FDA will conduct inspections to determine compliance with the BSE feed rule. Inventories of these firms may vary from year to year based on changes at the firm such as consolidations, business closures, relocations, etc. FDA will continue to update and improve the inventory of firms with information from states and other sources.
• Data Sources: FDA Field Data Systems.
• Performance: On August 4, 1997 FDA's regulation 21 CFR 589.2000 (Animal Proteins Prohibited From Use in Animal Feed) became fully effective. The purpose of the regulation is to prevent the establishment and amplification of BSE through animal feed. The regulation prohibits the use of certain proteins derived from mammalian tissue in feeding to ruminant animals. FDA has developed a three-pronged aproach in its efforts to realize 100% compliance with the 1997 feed rule--education, a strong and visible inspection presence, and enforcement action. More than 12,000 inspections have been done since 1997 at over 10,000 firms including renderers, feed mills, ruminant feeders, protein blenders, feed haulers and distributors.
  Based on the change in priorities, the goal has been changed to include re-inspection of 100 percent of firms found to be out of compliance, 100 percent of renderers, protein handlers, and feed mills, handling prohibited material, and as many other firms in these businesses, as resources allow, that we currently have listed as not handling prohibited materials, and to conduct sample analysis as needed to assure compliance with the BSE regulation. The need to perform BSE inspections became a higher priority in FY 2001 because of the increase in reported cases of BSE in Europe. To minimize the risk of BSE introduction into US cattle herds and to protect the health of American citizens, the program received contingency funding.

2.5.3 Verification and Validation

An integral part of the FDA continual improvement initiative has been upgrading our data processing and information systems. This includes automation of manual systems and integration of existing systems, which reduces duplication and chances of data entry errors. Our information and data collection systems contain automatic data checks such as comparisons against lists of "valid" responses for a given data field. By programming "business rules" into our systems, the chance for "human" error is reduced. For example, due dates for applications are appropriately assigned and review time is accurately tracked. Data access is restricted to ensure that only appropriate personnel can enter data, review data, or audit the data. For example, checks are in place to ensure that the person who enters the data does not audit the data.

In the postmarket area we are working with data from other governmental agencies such as CDC and USDA. To ensure that our federal partners address our data needs, we have established memorandums of understanding and memorandums of need with other agencies. To accomplish our Food Safety Initiative goal (Performance Goal 9 - NARMS), we entered into Interagency Agreements for the development of databases. Therefore, we are dependent on the data validation processes of our sister agencies.

Some of our program work is dependent upon other agencies' planning processes. This is especially true in our illegal residues in meat and poultry program that has responsibility to follow-up on violative tissue residues reports from USDA. USDA prepares an annual residue sampling plan with input from FDA. Under the new Hazard Analysis Critical Control Point (HACCP) plan, the requirements for how slaughter plants choose samples for testing has changed substantially. USDA's Food Safety Inspection Service takes some samples, but only if an animal is suspect. Since the USDA residue plan has changed, it is extremely hard to judge how many residue reports will be sent to FDA for follow-up investigation.

We have also ensured Year 2000 compliance of our data systems, including data applications. The Animal Drugs and Feeds program, in conjunction with the Agency, developed a plan to create an inventory of data applications, analyze their degree of Year 2000 compliance, and developed a plan to ensure compliance with Year 2000 requirements. The Animal Drugs and Feeds Program developed the Business Continuity Contingency plan for both of our critical data systems, STARS and DERS. We have upgraded our network, tested our servers and desktop units, and replaced the twenty units that were not Year 2000 compliant.

Contact Information:
Planning Staff, Office of Planning, FDA
Phone: 301-827-5210

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