2.4 ANIMAL DRUGS AND FEEDS

2.4.1 Program Description, Context, and Summary of Performance

The mission of the Animal Drugs and Feeds Program is to protect the health and safety of all animals that serve either as companions or food sources for mankind; 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 drugs and feeds.

These strategic goals reflect CVM's involvement in the animal drug development process from the point at which the drugs are first developed to after 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 working with partners in industry, academia, consumers, and other government agencies.

CVM's approach to achieving these strategic goals, and some of the key performance goals that support these strategic goals are explained in the following sections.

FY 99 Program Accomplishments

The Animal Drugs and Feeds Program has worked with our partners in Industry to redesign the New Animal Drug Approval Process to make it more efficient. This collaboration has served as a model for the development and passage of the FDA Modernization Act (FDAMA). Phased Review makes drug review faster by providing more timely feedback and "early detection" of application deficiencies. Electronic submission of Drug Shipment Notices cut the approval time to one third of the original time. CVM continues to increase the number of isolates in the National Antimicrobial Resistance Monitoring System (NARMS) database and achieves a very high conformance rate to FDA regulations of all domestic animal drug and feed manufacturing establishments and repackers.

2.4.2 Strategic Goals

Strategic Goal 1:

Approach

Veterinarians and the agricultural community need animal drugs to ensure a safe food supply. As disease-causing agents mutate and become resistant to current drugs, new drugs are needed. The availability of safe and effective drugs allows food animal producers to maintain healthy animals with assurance that products will be safe, wholesome, and free of drug residue when they reach the consumer.

CVM strives to increase the availability and diversity of animal drugs and feeds by being involved through out the new animal drug approval process.

Working with industry early in the drug approval process in pre-submission conferences (Performance Goal 1), workshops, teleconferences, and the availability of CVM guidances through the internet help increase industry efficiency, thereby reducing overall developmental costs. Phased review provides more timely feedback and "early detection" of application deficiencies.

The Agency is committed to improving the review time on new animal drug applications (NADAs) as well (Performance Goal 2). Reinventing the approval process (Performance Goal 3) and improved information systems such as electronic submission of applications (Performance Goal 4) and enhancements to the Submission Tracking and Review System (STARS) will allow FDA to more efficiently perform review activities.

To ensure that FDA has the necessary science base to make regulatory decisions, a staff college is being developed (Performance Goal 5) and risk assessments are being conducted (Performance Goal 6).

These 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 is capable of producing outcomes that matter to the US Taxpayer: reduced mortality and morbidity rates due to safer animal products, shortening the cost and time associated with animal drug development, and improved quality of life for selected segments of the human population because of healthy companion animals that have greater longevity.

Research and Standard Setting

Research and standard setting contribute to increasing the availability and diversity of animal drugs and feeds by promoting development of drugs for minor species and allocating scarce resources more efficiently by conducting risk assessments.

Animal drug studies are conducted to prove that the drug is safe and effective in the target animal. But because the rate for recouping drug research related to minor species (sheep, rabbits, fish) is low compared to major species (cows, pigs, poultry), most companies are reluctant to fund minor species research. The term "grouping" refers to combining animals with similar physiology in one group for research purposes, e.g., types of fowl and poultry together. The grouping of animal species will encourage minor species drug development, especially in the area of aquaculture.

The impact of improving risk assessments will be to quantify 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. Based on current resource estimates and complexity of the proposed risk analysis, CVM will initiate 2 risk analyses in FY 00 which will be completed in FY 01.

Leveraging and Communication

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 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 through the drug development process by communicating requirements (or standards or criteria) for approval at each stage of development.

Staff College programs have been developed in FDA as a means of developing intellectual capital. The addition of a CVM Staff College will allow CVM to increase and maintain the scientific expertise in the Center, especially as it relates to animal science and veterinary medicine issues. The Staff College will use dollars to outsource the planning and implementation of training programs tailored to the needs of in-house scientists.

Collaboration with other agencies such as the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA) is accomplished through interagency agreements. FDA also funds extramural research via contract and cooperative agreements and through collaboration with the University of Maryland known as the Joint Institute for Food Safety and Applied Nutrition (JIFSAN).

Reinvention

In order to increase the availability and diversity of safe and effective products, CVM is reinventing the new animal drug review process in two major ways. First, the Animal Drugs and Feeds Program is implementing the Animal Drug Availability Act¹ of 1996 (ADAA), the FDA Modernization Act (FDAMA)² and our reinventing government (REGO) initiative. This involves developing guidance documents which will more accurately reflect the current veterinary medicated feed and drug approval/monitoring processes. These standards reflect changes in the approval processes that have resulted from enactment of the ADAA and CVM's efforts to reinvent its new animal drug approval processes. Availability of guidance documents facilitates the accurate and complete preparation of drug applications.

Secondly, CVM is also helping to reduce drug development and review time by initiating the final and most complex phase of electronic submission, receipt of protocols. Although CVM currently receives some protocol data electronically, there are no standards approved for electronic filing and receipt of a hard copy is still required. The development of these standards will meet the requirements of the government's Paperwork Reduction Act allowing the electronic file to be the official file. Better automated information systems, including those supporting electronic submission of applications by sponsors, are being developed to facilitate and expedite the review process. CVM successfully completed a pilot project to permit one type of electronic submission for review and plans to expand the submission program to include other regulatory reporting requirements.

B. Summary of Performance Goals

C. Goal-by-Goal Presentation of Performance

1. Increase the level of pre-submission conferences with industry sponsors to 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 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 through 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. Based on current data, 75% is a reasonable target for FY 00.

2. Review and act on 70% of NADAs/ANADAs within 180 days of receipt. (14017)

• Context of Goal: The animal drugs and feeds program does not have sufficient resources to review and act on all new animal drug application actions received within the statutory time frame of 180 days. Recent resource increases in the drug review area will allow the Center for Veterinary Medicine to recruit and hire review scientists. The increased manpower will increase our compliance rate from 65% in FY-00 to 70% in FY-01.
• Data Sources:Submission Tracking and Review System (STARS)
• Performance: In FY 99, CVM updated its tracking system to be consistent with procedures under ADAA. Current data indicates a compliance rate of 65% is reasonable for FY 00.

3. 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 which will more accurately reflect the current veterinary medicated feed and drug approval/monitoring processes. These standards reflect changes in the approval processes resulting from enactment of the ADAA and CVM's efforts to reinvent its new animal drug approval processes. Availability of guidance documents facilitates the 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 1999 and will be continued in FY 00. 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.
• Data Sources: CVM's priority project tracking system.
• Performance: By the end of FY 98, there were 77 guidance documents related to the Animal Drugs and Feeds Program. 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 Veterinary International Conference on Harmonization (VICH). One of the FDAMA guidances is related to dispute resolution and another to supplemental applications.

Reinvention Success Stories:

Reinvention in CVM has succeeded in part because it has been a collaborative process between FDA and our regulated industry. In order to implement the Veterinary Feed Directive (VFD), statutory changes were required. The collaborative process was used to develop the necessary legislation. The VFD project led to a collaborative effort to address additional drug approval processes. The result was the passage of the Animal Drug Availability Act (ADAA). This collaborative process was used as a model for the development and passage of FDAMA. CVM continues to interact with industry to clarify reinvention regulations and develop guidance documents that address industry concerns.

4. Reduce drug development and review time by initiating a process for receiving protocol submissions electronically. (14002)

• Context of Goal: The Results Act and FDAMA require input from our stakeholders. Feedback from our stakeholders indicated that better automated information systems, including those supporting electronic submission of applications by sponsors, would facilitate and expedite the review process. In 1998, CVM initiated a pilot project to permit industry to electronically submit one type of notice for review. Plans were developed to expand the submission program to include other regulatory reporting requirements.
• Data Sources: CVM's priority project tracking system.
• Performance: In 1997 FDA initiated the development of the infrastructure and procedures to allow for electronic submissions. In 1998, FDA worked with industry to successful complete a pilot to permit electronic submissions of Notices of Claimed Investigational Exemptions (NCIE-also known as drug shipment notices). In 1999, the Animal Drugs and Feeds Program completed the implementation of the electronic submission process for all NCIE submissions. An evaluation of the process shows improvement in application processing time. Processing time was reduced to 1/3 the time required for paper processing. Additional phases of electronic submission are being initiated in FY 00. 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.

Electronic Submission Success Stories:

Feedback from our regulated industry indicates that the electronic submission process used in the pre-market approval process was such a success that CVM is going to use the same process for transmitting material to FDA in the postmarket assurance process. We have shared information on our success at veterinary international harmonization meetings and have proposed using our process as the model for international electronic submissions.

5. Leverage our intellectual capital by initiating the development of a Staff College in the 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 developing intellectual capital. The addition of a CVM Staff College will allow CVM to increase and maintain the scientific expertise in the Center, especially as it relates to animal science and veterinary medicine issues. The Staff College will use dollars 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 00: Develop a strategy to establish a Staff College in CVM; FY 99: Identify need to enhance and maintain scientific expertise

6. Develop an antibiotic risk assessment model using FLQ as the antibiotic, Chickens as the animal species and Campylobacter as the bacterial isolate.(14003)

• Context of Goal: The impact of improving risk assessments will be to 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. Based on current resource estimates and complexity of the proposed risk analysis, CVM will initiate 2 risk analyses in FY 00 which will be completed in FY 01.
• Data Sources:The NARMS database mentioned later in this report, surveillance systems of other government organizations, such as those of CDC and USDA, and published literature.
• Performance: The Center has used the principles of risk assessment to determine that the microbial safety of all antibiotics used in food animals must be assessed prior to approval. The guidance explaining this risk assessment was published November 1998. A risk assessment that evaluated the risk to human health from resistant food borne pathogens associated with the use of antimicrobials in food producing animals was completed in December 1999. The draft risk assessment report was made available on the CVM homepage and was discussed at a workshop held December 9-10, 1999, and attended by over 200 interested participants from industry, public health, consumer groups, other governments and other US government agencies, and the press. The risk assessment models the risk of having a resistant Campylobacter infection attributable to the use of fluoroquinolones in chickens and being treated with a fluoroquinolone. At the workshop the report was applauded for its thoroughness, logical flow, and novelty. A docket was opened to allow people who could not attend the workshop to comment on the risk assessment as well. CVM plans to continue to have a process that is open for public input as it determines what standards to apply to risk assessment results in establishing monitoring thresholds for antimicrobial resistance associated with the use of antimicrobials in food animals.

CVM will be developing a second risk assessment model to assess the transfer of resistance determinants to human pathogens from enterococci originating in 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. The Center published a request for proposals to develop the model and awarded a contract in September 1999.

Strategic Goal 2:

Approach

Once animal drugs are on the market, CVM continues to be involved in managing public health risks by improving/enhancing our compliance strategy and the development of partnership relationships with industry and the states.

Surveillance of marketed products and the business industry is accomplished through review of drug experience reports and compliance programs implemented by the FDA field offices through inspections (Performance Goal 7, 8 & 9), sample collections and analysis, investigations, and other activities. Regulatory actions are taken as needed to control violative goods and firms.

The immediate outcome of our surveillance systems is the identification of potential human and/or animal health hazards. An intermediate outcome is the development of 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 withdrawal of marketed drugs as necessary to protect human and animal health. The ultimate outcome is assurance that marketed animal drugs and food additives provide for safe food products derived from animals and ensure quality health care of animals.

Another major post market concern of CVM is the President's Food Safety Initiative. The U.S. population needs an effective early-warning system (Performance Goal 10) that can detect food illness outbreaks early and allow implementation of intervention strategies to prevent their spread. NARMS was developed in conjunction with USDA and CDC, and has greatly improved our ability to detect emerging resistance among foodborne pathogens. This helps ensure the continued effectiveness of both human and veterinary drugs and aids in increasing the availability and distribution of effective drugs. This system also advances understanding of foodborne illness and further prevention efforts.

Research and Standards Setting

Food safety research is critical to developing the means to more rapidly and accurately identify and characterize foodborne risks. This will provide the tools for regulatory enforcement and the development of effective interventions to be used, as appropriate, to prevent hazards at each step from production to consumption.

In order to continue to ensure a safe food supply, USDA must be able to monitor livestock and poultry for illegal drug residues and contaminants at the time of slaughter. FDA is responsible for conducting follow-up investigations. In order to determine the source of the contamination/adulteration, FDA needs to evaluate emerging techniques, develop new techniques, and adapt techniques in order to detect residues/contaminants in animal derived food, animal physiological samples and animal feeds. For example, we will expand the development of modeling techniques for assessing human exposure to a variety of foodborne pathogens and develop animal models for assessing infectivity.

Leveraging and Communication

In order to assure that foods from animals are safe for human consumption, FDA works with other government agencies, state and local governments, and the private sector to take action to prevent or minimize potential public health hazards through development of early warning systems, investigations, risk assessment, scientific research, educational initiatives and regulatory action.

CVM partners with other federal and state agencies, our stakeholders, and regulated industry to develop and sponsor workshops, symposia, and publications with a focus on prevention in order to assure the public that accurate information is disseminated and that marketed animal drugs and feeds are safe and effective.

CVM is making a strong effort to educate its partners in industry by publishing and disseminating guidance, training initiatives in targeted high-risk compliance areas, and in working more closely with industry to resolve problems.

FDA is also involved in international harmonization activities that will remove trade barriers while ensuring the American public that imported products meet FDA's standards related to safety and efficacy. Part of the harmonization effort includes the development of Mutual Recognition Agreements (MRAs) that will address international equivalency issues. FDA must be able to assure the public that the processes used in other countries are as good as the processes in this country and the resulting products are safe for the intended use. Harmonization activities have been initiated with the European Union and Japan. The assessment of member state regulatory systems is an essential step in the harmonization process.

FDA is dedicated to expanding NARMS by initiating the collection of bacterial isolates from other countries. We decided to begin the expansion by collecting isolates from a neighboring country. Mexico was chosen because it borders on the US, it supports our initiative to partner with Latin American countries, and it is cost effective. The purpose is to identify bacterial trends in Mexico and take action to prevent a foodborne outbreak in the US. In FY 99, we laid the groundwork to establish the international relationship that will ensure the projects success.

B. Summary of Performance Goals

C. Goal by Goal Presentation of Performance

7. Improve biennial inspection coverage by inspecting 46% 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 feed establishments once every 2 years. There continues to be an increased emphasis on postmarket monitoring as a result of public demand for increased drug availability. Routine inspections have lower priority than inspection of firms producing high profile products. This has an impact on the pre-approval process which requires a "recent" inspection prior to 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.
Biennial inspection means we are to inspect 50% of registered establishments every year. As of September 1999, there were 1,418 registered establishments.

• Data Sources: Program Oriented Data System, Official Establishment Inventory
• Performance: FY 98: 34%, FY 97: 31%

In 1999, 25% of registered animal drug and feed establishments were inspected, falling just short of our target of 27%. The inspection percentages are estimates, based on complexities of inspections, number of firms in inventory, time each inspection takes, and violative and reinspection rates.

8. 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 a high level of conformance (at least 90%) with FDA requirements. (14004)

• Context of Goal: Routine postmarket surveillance activities and surveys are conducted to assure that sponsors are in compliance with regulations designated to ensure data integrity and good manufacturing practices.
• Data Sources: FDA Field Data Systems.
• Performance:The FY 99 conformance rate is 99%. FY 98: 98% FY 97: 97%. 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 the given year. As the statistical model and industry coverage is improved, the rates will better represent the conformance status of the overall industry. The FY 99 conformance rate does not include BSE medicated feed inspection data.

9. Protect public health (human) and animal health by ensuring compliance with good manufacturing practices including the newly implemented BSE (Mad Cow Disease) regulation through education, regulatory inspections and industry/Federal/state partnerships. (14006)

• Context of Goal: CVM sought to protect the public through the development of regulations and a comprehensive strategy to educate the industry. Surveillance activities were initiated to ensure compliance with the Bovine Spongiform Encephalopathy (BSE) regulations. In 1998, a program was initiated to decrease the feeding of prohibited materials to ruminants. The program began with a satellite conference and a two year plan to conduct educational inspections aimed at improving the labeling and record-keeping requirements, inspecting foreign processors and domestic importers of bovine materials, and implementing laboratory tests for compliance with the BSE regulation.
• Data Sources: FDA Field Data Systems
• Performance: Progress: We have completed over 7,200 inspections to determine compliance with 21 CFR 589.2000. The non-compliance rate continues to be approximately 25%. The educational aspects of the inspections are resulting in understanding of the requirements by the firm/individual and the majority of the firms are taking corrective actions to bring the company into compliance. Follow-up inspections are now being scheduled to assure that firms have implemented corrective actions.

The June 1999 Update Workshop was conducted in Dallas, Texas, with over 170 participants. The workshop was very interactive and focused on problem solving, continuing education of the affected parties, and targeted enforcement action for repeated violators. In addition, CVM continues to provide speakers for state and industry training. CVM is working with ORA to develop interactive Computer Based Training for BSE Feed Regulation inspections. This training initiative includes representatives from CVM, ORA headquarters, FDA field, and the states. We anticipate completion early in FY 2000. Some distribution, start-up, and training in the use of the module will be required.

Percent BSE Inspections Completed by Year



BSE Success Stories:

In March 1996, the British government announced its concern that exposure to BSE-infected beef might cause human disease. This concern grew because of a possible link between BSE (often called "mad cow" disease) and 22 cases of a newly identified variant of Creutzfeldt-Jakob Disease in humans. The potential impact on animal and human health and the high public health cost of a BSE epidemic in the U.S. led to the passage of BSE regulations. The enforcement of the BSE rule is a high priority for the Agency. FDA has worked with the regulated industry to ensure that the industry understands and complies with the regulations.

A major objective in preventing BSE in the U.S. is to inspect and educate all renderers, feed manufacturers, and a percentage of ruminant feeders. A significant number (89%) of these inspections have been completed and some states and FDA Districts are beginning to conduct follow-up inspections at those firms that were not in compliance. In FY 00, we will complete the planned initial inspections and continue to devote resources to determine whether corrections have been made.

10. Increase the overall isolate testing rate for Salmonella in NARMS to 7200 for human and animal isolates. (14005)

• Context of Goal: A major part of the surveillance aspect of the CVM's Food Safety Initiative (FSI) is NARMS which was initiated in 1996 in collaboration with FDA, CDC, and USDA . It allows the detection of emerging resistance among foodborne pathogens and the detection of potential health hazards through systematic collection, analysis and interpretation of antimicrobial susceptibility surveillance data. In addition, the program serves as a basis for educational efforts and prudent drug use campaigns in humans and in veterinary medicine. It helps ensure the continued effectiveness of both human and veterinary drugs.
• Data Sources:FDA-CDC-USDA National Antimicrobial Resistance Monitoring System
• Performance: We continue to meet our NARMS goals. Our CY 98 human target was 1000 salmonella isolates and we added data from 1466 isolates to the database. The veterinary target was 3000 and data from 3318 isolates was added to the database. Calendar Year 99 data appear to be on target (CY 99 target: - 2000 human and 4000 animal isolates). Early estimates indicate that we should receive approximately 1600 human salmonella isolates and 5000 animal salmonella isolates during this period.

Date of Completion: The final results for CY 99 will be available about April 2000. The isolates will be collected through December 31, 1999, then sent for serotyping, susceptibility testing, and quality control testing. Reports will be generated and analyzed.

Salmonella Isolates in NARMS



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 Salmonella, Campylobacter and E. coli isolates collected from animal sources, and Salmonella Campylobacter, Enterococcus, Shigellaand E. coli isolates from human clinical samples. In addition, new sites and sources of isolates have been added.

Epidemiological research was initiated in 1998 and expanded in 1999. This research aims to characterize and reduce the incidence of food borne disease associated with emerging and drug-resistant pathogens. Information from this research was used in 1999 to educate farmers about proper drug use and other husbandry practices that would help prevent future outbreaks and spread of the multi-resistant organism, Salmonella typhimurium DT104, among animals and to man. Collaborative studies with USDA will significantly improve FDA's ability to monitor the safety of competitive exclusion products and new antimicrobial approvals.

NARMS data has been presented at National and International meetings. Medical microbiologists from hospitals in Mexico and Guatemala are interested in initiating an antimicrobial resistance-monitoring program. This collaboration between the 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.

Human Isolates Tested by Year

2.4.3 Verification and Validation

An integral part of the FDA continual improvement initiative has been an upgrade of our data processing and information systems. This includes automation of manual systems and integration of existing systems which reduces duplication and chances of data keying 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. (Checks are in place to ensure that the person who enters the data does not audit the data, etc.)

As part of our commitment to seek input from our stakeholders, we are working with industry to be sure that our preapproval performance measures are appropriate for our stated goals. As we gain experience, we are making changes to ensure that appropriate data are reported. For example, we originally reported progress related to guidance documents as percent revised. We improved the measure by changing it to reflect the actual number of revised guidances updated/developed.

In the postmarket area we are working with, and using data from, other governmental agencies such as CDC and USDA. To ensure that our data needs are addressed by our federal partners, we have established memorandums of understanding and memorandums of need with other agencies. In order to accomplish our Food Safety Initiative goal (Performance Goal 10 - NARMS) we developed databases in-house and entered into Interagency Agreements for the development of other databases. We are therefore dependent to some extent 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 which targets the follow-up of violative tissue residues received from USDA. USDA prepares an annual residue sampling plan with input from FDA. Under the new Hazard Analysis Critical Control Point plan, the requirements that slaughter plants sample has changed substantially. USDA's Food Safety Inspection Service takes some samples, but only if an animal is suspect. Because 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 thus develop 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 desk top units, and replaced the twenty units that were not Year 2000 compliant.

____________________
¹ ADAA substantially alters the way FDA regulates and approves animal drugs and medicated feeds by granting the authority to exercise considerable flexibility in regulatory decision-making. During the implementation phase which includes promulgation of regulations through notice and comment rulemaking, FDA is continuing the dialogue with stakeholders that began prior to the passage of the ADAA.

² FDAMA initiatives in the Animal Drugs and Feeds Program premarket area requires the Center to accomplish the following: 1) develop guidance regarding the content and review of applications and supplemental applications for approved products; 2) participate in the development of reports and publications required to meet all statutory review requirements by July 1, 1999; eliminating backlogs of applications under review by January 1, 2000; 3) participate in the development of an information system to track the status of applications described in the act; and 4) participate in the development of training and education programs for employees.

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