| Total Program Resources (FY 2000): | $000 | FTEs | |
| Center | 36,375 | 293 | |
| Field | 16,098 | 176 | |
| Total | 52,473 | 469 |
The Center for Veterinary Medicine is responsible for increasing the availability and diversity of safe and effective veterinary products that relieve pain and suffering, sustain health, improve animal productivity, and do not compromise public health. The primary goals are to: 1) ensure that only safe and effective animal drugs, devices, feeds and feed additives are marketed; 2) ensure that foods from animals that are administered drugs and food additives, in accordance with label directions, are safe for human consumption; and 3) to work proactively to increase the availability and diversity of safe and effective products for use by the agricultural community.
The Agency strives to process New Animal Drug Applications (NADAs) as quickly as possible to ensure that only safe and beneficial veterinary drugs, intended for the treatment and/or prevention of diseases in animals, and the improved production of food producing animals, are approved for use. In addition, FDA maintains continuing surveillance over all animal drugs, devices, and feeds marketed in interstate commerce in order to minimize threats to human and/or animal health which might arise as a result of the use of these products.
Surveillance of marketed products and the regulated industry is accomplished through review of drug experience reports and by the FDA field offices through inspections, sample collections and analysis, investigations, and other postmarket activities. Regulatory actions are taken as needed to control violative goods and firms.
Methodology development and validation as well as collaborative studies are accomplished through in-house research at the Center for Veterinary Medicine Research Office in Laurel, Maryland, the Veterinary Research Center in Denver, Colorado, and via special projects in FDA's other laboratories. 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).
| Resources: | $17,515,350 | 207 FTEs |
Performance Goals:
Rationale:
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. Over time, animal drug use moved from therapeutic treatment to save individuals or herds of animals intended for human consumption to the routine use of production drugs, which helps the producer maintain a profit margin while keeping safe and wholesome animal products at a reasonable cost for the average American consumer. Today's approval process not only addresses the effectiveness of drugs or chemicals, but also determines withdrawal times, which ensure that the animal product is residue-free when offered for purchase to the consumer.
In addition, the approval process includes bioresearch monitoring. Bioresearch monitoring is an integral part of the pre-market application review process. Inspections assure that sponsors are in compliance with regulations and good laboratory practices are followed. Bioresearch monitoring inspections provide a mechanism to alert the Agency to potential problems. FDA works with the industry to ensure that they are actually capable of producing the product under review and that the data supporting the review is valid.
Availability of safe and effective drugs affects the health and well-being of companion as well as food producing animals and provides the U.S. citizen with an economical and safe food supply. In addition to the economic impact on the agricultural community, an immediate outcome is increased availability of drugs to treat companion animals, thereby increasing their life span and the quality of life. Studies have shown that companion animals have a positive effect on the quality of life of selected segments of the human population. Companion animals are used to increase independence of individuals with disabilities such as guide dogs for the blind, working dogs for the deaf, and a variety of animals that assist physically challenged individuals. The elder population and individuals in institutions also appear to benefit from associations with companion animals, according to recent studies.
In order to increase the availability and diversity of safe and effective products, the Animal Drugs and Feeds Program will expedite and facilitate the approval of new animal drugs by implementing the Animal Drug Availability Act(1) of 1996 (ADAA), the FDA Modernization Act (FDAMA)(2) and our reinventing government (REGO) initiative. The Animal Drugs and Feeds Program will inform and assist product sponsors throughout the approval process starting with the pre-submission conference. The focus will be on informing and assisting firms in complying with the new legislation and streamlining the product review process by continuing the implementation of the phased review process. Streamlining efforts will be focused on reducing the overall time required for drug development from product conception by the drug sponsor through the Investigational New Animal Drug phase to the new animal drug approval. FDA has initiated processes to obtain input from our stakeholders in order to develop meaningful performance measures to assess progress consistent with our 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 successfully completed a pilot project to permit one type of electronic submissions for review and plans to expand the submission program to include other regulatory reporting requirements.
The immediate outcome from these performance goals will be a decrease in the developmental time and costs associated with research studies and other drug approval regulatory requirements. Pre-submission conferences and availability of CVM guidelines through the Internet and workshops will help increase industry efficiency, thereby reducing overall developmental costs. There will be more industry collaboration and partnerships to expedite the process. Phased review will provide more timely feedback and provide "early detection" of application deficiencies.
Another immediate outcome is an overall shortened review time. The change in processes is designed to decrease overall review time thereby increasing the availability of safe and effective animal drugs. Phased review coupled with improved information systems such as electronic submission of applications and enhancements to the Submission Tracking and Review System (STARS) will allow FDA to more efficiently perform review activities. This will enable the agricultural community to more effectively provide animal derived products, possibly at a lower cost due to the reduced animal drug developmental costs being reflected in lower costs to purchasers.
A primary ultimate outcome is safe animal products for human consumption. 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.
Approaches, Skills, Technology, and External Factors:
Resources are primarily devoted to new animal drug review, but also include surveillance activities in the field, as well as research that supports the review process.
A sponsor notifies CVM about the development of a new animal drug. CVM works with the sponsor to set up a pre-submission conference. The conference can be conducted in person or by audio or video teleconference. Information exchange continues throughout the research and development process. As the sponsor completes a technical section (the different pieces of a New Animal Drug Application), it is submitted to CVM for review. The technical sections include target animal safety and effectiveness, manufacturing methods and control chemistry, residue chemistry and regulatory methods, human food safety, and environmental safety.
Guidance documents are available to industry to facilitate the accurate and complete preparation of drug applications. Development of new guidance documents and updating existing documents to reflect recent changes in legislation will be initiated in FY 1999 and continued in FY 2000. Dependent on workload and reviewer expertise guidance documents will be reviewed and updated.
In addition to teleconferences, FDA uses the Internet technology to support electronic submission of data and to post guidance documents for stakeholders' access.
The results of routine postmarket surveillance activities and special surveys conducted to assure that sponsors are in compliance with regulations are used in the pre-approval process to ensure data integrity and Good Manufacturing Practices. Pre-approval inspections are also conducted as needed to enhance understanding and confirm that the sponsor has the ability to produce a safe and effective product.
Research is an essential element in the approval process. Method validation studies are necessary in approving applications for new drugs for food animals.
Information system development improves the ability of primary reviewers to access Agency and sponsor data used in the review process.
New animal drug review activities are supported by scientific research, data collection, and analysis. Review activities are conducted primarily by staff in CVM's Office of New Animal Drug Evaluation with support from other parts of the Center. Scientists provide guidance and assistance to industry, consumers, and other constituencies regarding regulatory interpretations related to animal drugs and feeds. They also serve as national experts by providing technical expertise for the development and harmonization of international specifications and standards in the area of veterinary medicine.
Performance Goals, Data Sources, and Baselines:
Goal Statement: Update 10 percent of the animal drug review guidelines which serve as aids to industry in the animal drug review process.
Data Sources: CVM's priority project tracking system.
Baseline Data:
FY 1998:
Review guidance documents to identify documents
for preparation or rewriting.
FY 1999: 1% (target)
Goal Statement: Review and act on 65 percent of New Animal Drug Applications (NADAs)/Abbreviated New Animal Drug Applications (ANADAs) within 180 days of receipt.
Data Sources: Submission Tracking and Review System (STARS)
Baseline Data:
FY 1997: 75%
FY 1998: 75%
FY 1999: 65 % (target)
Goal Statement: Maintain a 75 percent level for pre-submission conferences with industry sponsors.
Data Sources: Submission Tracking and Review System (STARS)
Baseline Data:
FY 1997: 75%
FY 1998: 75%
FY 1999: 75% (target)
Goal Statement: Reduce drug development and review time through implementation of additional phases of electronic submission in the investigational new animal drug development process.
Data Sources: CVM's priority project tracking system.
Baseline Data:
FY 1997:
Initiated the development of infrastructure/procedures
FY 1998:
Completed pilot to permit electronic submissions of
Notices of Claimed Investigational Exemptions (NCIE)
FY 1999:
2 phases (target):
Drug Shipment Notices
Notices of Slaughter
Goal Statement: Increase bioresearch monitoring inspections completed and results received to 115.
Data Sources: CVM Bimo Tracking Database
Baseline Data:
FY 1997: 57 inspections
FY 1998: 46
FY 1999: 50 (target)
| Resources: | $27,257,650 | 232 FTEs |
Performance Goals:
Rationale:
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, sample collections and analysis, investigations, and other activities. Regulatory actions are taken as needed to control violative goods and firms.
FDA has a statutory obligation to inspect all regulated animal drug and feed establishments once every two years. Currently we are inspecting these establishments once every four years. At the same time there has been an increased emphasis on postmarket monitoring as a result of public demand for increased drug availability. With limited resources, 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.
Drug Experience Reports, including Adverse Drug Event (ADE) data on adverse drug reactions, are important in the monitoring for reactions that were not found in the preapproval research trials. The immediate outcome of our surveillance systems is the identification of potential human and/or animal health hazards. A group of similar reports submitted in a short period of time may alert CVM and the drug company to a problem with a particular lot of drug. This may result in a product recall of that affected lot. We plan to integrate our database with an Agency database to better monitor the interaction of products and provide baseline data on the rate and characteristics of injuries. Another intermediate outcome would be for a label change to include new information gleaned from reported ADEs. 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. Veterinarians in practice depend on the information available in drug labeling to make informed choices about the risks and benefits associated with the use of a drug. 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.
In addition to information on the label, veterinarians and other health care professionals are influenced by the promotion and advertising activities of the industry. FDA protects practitioners and the general public by reviewing such material for false and misleading promotions. Inaccurate or false information can lead to a compromise of therapy which can result in injury or death. The immediate advertising and promotion review outcome is a decrease in fraudulent and misleading information which promotes off-label use. The ultimate outcome is a reduction in the use of ineffective treatments and associated economic fraud.
The CVM drug listing database, in conjunction with ADE data is a powerful tool that allows CVM to properly serve the veterinary and animal health community, by providing information on approved and unapproved products, and veterinary drug shortages. This information enables proper surveillance and monitoring of the animal drug and feed industry, and therefore gives CVM the ability to act proactively to avert crises before they happen.
CVM is improving outreach efforts in the area of consumer education and feedback by using state-of-the-art communication technologies including publicizing information in a dedicated section of the CVM home page that incorporates issues of consumer interest and provides a mechanism for consumer comment. CVM is also 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.
Approaches, Skills, Technology, and External Factors:
Resources are primarily devoted to monitoring and surveillance activities including FDA Field inspections/investigations, data review and analysis, educational initiatives, scientific research, and development of compliance and enforcement strategies.
FDA will reduce the availability of unsafe animal drugs through improving/enhancing our compliance strategy. Through development of partnership relationships with industry and the states, we will implement the ADAA through new regulations, implement the FDAMA requirements, and develop educational initiatives. As needed, we will develop enforcement strategies to assure public safety.
CVM is notified about potential postmarket problems via one or more of our early warning systems. Center employees review National Antimicrobial Resistance Monitoring System (NARMS) data, ADE reports, Establishment Inspection Reports (EIRs), Contamination Response System (CRS) data, Tissue Residue Information System (TRIMS), Residue Violation Information System (RVIS), or other forms of communication. FDA then takes the appropriate action to address emerging issues, prevent or contain problems, and bring the animal drug industry into compliance.
Routine postmarket surveillance activities and special surveys are conducted to assure that sponsors are in compliance with regulations designated to ensure data integrity and Good Manufacturing Practices. 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.
Experience has shown that educational and partnership efforts are a good investment. Education and increased cooperation between FDA and regulated industry does decrease the need for enforcement actions and litigation. Recent decreases in our base budget have resulted in decreased training and other educational efforts. An increase in our base is needed to offset this trend.
Research is an essential element in postmarket assurance. Research studies are necessary in order to develop methods for detecting drugs, chemicals, pesticides, heavy metals, and microbial contaminants and residues that are potential health hazards.
Compliance and enforcement strategies are necessary in order to ensure animal and human health. Consumer Safety Officers utilize scientific and legal knowledge to develop and support strategies that encourage voluntary compliance and take enforcement action when necessary. Knowledge of food and drug law supports compliance activities and facilitates communications with FDA's Office of the Chief Counsel and the Department of Justice.
Program and systems analysts provide services and develop information systems focused on improving the ability of data exchange within the Agency and external to the Agency. Communication with the scientific community is an essential element in ensuring that FDA continues to make valid scientifically- based decisions.
Postmarket assurance activities are supported by scientific research, data collection, and analysis. Surveillance and compliance activities are conducted primarily by staff in CVM's Office of Surveillance and Compliance. Scientists, analysts, and Consumer Safety Officers in other parts of the Center such as the Office of Research and the Office of Management and Communications also support the postmarket assurance activities. Scientists provide guidance and assistance to industry, consumers, and other constituencies regarding regulatory interpretations related to the marketing and use of approved animal drugs and feeds. Consumer Safety Officers work with animal scientists, veterinarians, and the Office of Chief Counsel to ensure both human and animal health.
Performance Goals, Data Sources, and Baselines:
Goal Statement: 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 percent) with FDA requirements.
Data Sources: FDA Field Data Systems
Baseline data:
FY 1997: 95%
FY 1998: 95%
FY 1999: at least 90% (target)
Note about goal: Conformance rates estimate the post-inspection status of the establishments inspected in the given year. They are based on the number of establishments inspected, the incidence of serious deficiencies detected (Official Action Indicated), and statistical data of deficiency corrections. Since firms inspected are not randomly selected form the entire population, the rates should not be applied across that population. However, as coverage of the inventory of firms is improved, the rates will better represent the overall status of the industry sector.
Goal Statement: Meet the statutory biennial inspection requirement by inspecting 50 percent of registered animal drug and feed establishments.
Data Source: Program-Oriented Data System, Official Establishment Inventory
Baseline Data:
FY 1997: 31% of establishments inspected
FY 1998: 34%
FY 1999: 27% (target)
Note about Goal: 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.
Note about Baseline Data: Fiscal year baseline data is an estimate derived from two-year coverage data. Two-year coverage is computed by dividing the number of establishments inspected in the last two years by the total number of registered establishments. The fiscal year baseline estimate is half this number.
Goal Statement: Maintain the number of Adverse Drug Event (ADE) reports reviewed at 7,000 through consumer participation in the pharmocovigilance program for veterinary drugs by publication and distribution of educational material.
Data Sources: Adverse Event Reporting System.
Baseline Data:
FY 1996: 3345 ADE reports.
FY 1997: 4134 ADE reports
FY 1998: 8000 ADE reports
FY 1999: 7000 ADE reports (target)
Goal Statement: Improve our ability to monitor for Adverse Events by initiating the development of an integrated agency-wide system.
Data Sources: CDER/CVM Injury Reporting Database
Baseline Data:
FY 1998: Identified gaps in data
FY 1999: Determine data base/systems to be integrated
| Resources: | $7,700,000 | 30 FTEs |
Performance Goals:
Rationale:
Foodborne disease is a serious and growing problem in the United States. There are an estimated 6.5 to 33 million foodborne illnesses in the United States per year. There are approximately 9,000 deaths per year. The estimated hospital costs are $3 billion per year.(3) The U.S. population needs an effective early-warning system that can detect outbreaks early and allow implementation of intervention strategies to prevent their spread. Such a system will also advance understanding of foodborne illness and further prevention efforts.
A major part of the surveillance aspect of the CVM's Food Safety Initiative (FSI) is the National Antimicrobial Resistance Monitoring System (NARMS) which was initiated in 1996. This collaboration among FDA, CDC, and USDA to monitor bacterial foodborne pathogens for changes in antimicrobial susceptibility has greatly improved our ability to detect emerging resistance among foodborne pathogens and thereby help ensure the continued effectiveness of both human and veterinary drugs and aid in increasing the availability and distribution of effective drugs.
The initial effort in the development of an early warning system enabled the federal partners to identify the presence of a multi-drug resistant Salmonella typhimurium DT 104 (StmDT104) in humans and animals in the United States. This early warning of a potential epidemic, such as that seen in the United Kingdom, enabled CDC to warn state health departments of StmDT104's presence and to allow augmented monitoring for this pathogen. As a result, public health officials were prepared for the outbreak in Vermont and were in a position to take preventative steps to minimize the spread.
The impact of improving risk assessments will be to focus public resources on reducing those risks that have the greatest consequences for human health. 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 preventative controls.
Food safety research is critical to developing the means to more rapidly and accurately identify and characterize foodborne hazards to provide the tools for regulatory enforcement and to develop effective interventions that can be used, as appropriate, to prevent hazards at each step from production to consumption.
An integral part of the overall food-safety initiative is providing food safety education to a variety of audiences: consumers (the general public and specific groups at risk for foodborne illness); veterinarians, animal and other food producers. The challenge is to create effective education messages that address the risks relevant to each audience throughout the food chain.
The immediate outcome is an increase in our ability to detect new foodborne challenges and to intervene where possible to prevent or minimize disease outbreaks. The intermediate outcome is the development of strategies to address potential human and animal health hazards. The ultimate outcome is a decrease in foodborne illnesses among both humans and animals.
Approaches, Skills, Technology, and External Factors:
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, postmarket inspections and investigations, risk assessment, scientific research, educational initiatives and regulatory action.
Research is an essential element in postmarket assurance. Research studies are necessary in order to develop methods for detecting drugs and drug residues that may be present in food products derived from animals. In addition to methods development, analytical methods development research improves the effectiveness of monitoring for antibiotic resistance patterns as well as providing more rapid and accurate procedures to detect and quantify chemical substances in foods.
The NARMS was initially developed by expanding or redirecting existing programs in several federal agencies. The system is a collaborative effort of FDA, CDC, and USDA. The NARMS is the basis for regulatory decision making, food animal drug policy and identification of disease trends in human and animal medicine. It allows 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.
FDA and USDA work together to develop USDA's annual residue prevention sampling plan. The USDA Food Safety Inspection Service (FSIS) implements the plan using HACCP (critical control points) principles. If the sampling plan reveals a residue violation, FDA is notified via the USDA/FDA Residue Violation Information System (RVIS). FDA partners with the states to perform follow-up investigations. If this is a first time violation, through contracts and informal agreements, FDA trained state inspectors determine the "cause" of the violation and provide the educational information in order to prevent future violations. Feedback from the investigations is input into the Tissue Residue Information Management Systems (TRIMS). TRIMS data is used to identify trends and provide a basis for the development of additional educational material.
Increased activities in education in FY 1999 FSI include supporting government agencies and veterinary trade associations in the dissemination of antimicrobial "Judicious Use" or "Prudent Use" principles concerning treatment of food animals. In addition, conducting town hall meetings, symposia and inter-active teleconference with food animal veterinarians and producers in the U.S. and its trading partners so that all have a hand in developing a U.S. program that acknowledges the international guidelines.
A major portion of the educational increases will be done in partnership with state and local governments. FDA will work directly with state and local authorities who will facilitate the distribution of prudent and judicial drug use materials and programs developed by FDA. Other programs will be developed in conjunction with our state and local government agency counterparts. We will also partner with veterinary practitioners and producer groups as well as academia (veterinary medical schools) to increase awareness related to proper use of veterinary drugs.
Performance Goals, Data Sources, and Baselines:
Goal Statement: Maintain the bacterial isolate testing rate from human and animal origin in the National Antimicrobial Resistance Monitoring System (NARMS) database at 2,000 and 4,000 respectively.
Data Sources: FDA-CDC-USDA National Antimicrobial Monitoring Program
Baseline Data:
Calendar Year 1996:
Salmonella Isolates: 1272 Human, 1921
Veterinary
Calendar Year 1997:
Salmonella Isolates: 1287 Human, 2391
Veterinary
Calendar Year 1998:
Salmonella Isolates: 1400 Human, 3500
Veterinary
Calendar Year 1999:
Salmonella Isolates: 2000 Human, 4000
Veterinary (target)
Goal Statement: Properly target resources related to education and enforcement initiatives by maintaining the number of follow-up violative tissue residues investigations at 600 in targeted food-producing animals.
Data Sources: Residue Violation Information System (RVIS); Tissue Residue Information Management System (TRIMS)
Baseline Data:
FY 1996: 727 tissue residues
FY 1997: 423
FY 1998: 500 (target)
FY 1999: 600 (target)
Goal Statement: Increase the scientific basis for prioritizing research and surveillance activities by increasing the number of risk assessments performed regarding antimicrobial products to two per year.
Data Sources: CVM's priority project tracking system
Baseline Data:
FY 1999: 1 assessment (target)
Goal Statement: Expand the geographical scope and capacity of the National Antimicrobial Resistance Monitoring System (NARMS) by the establishment of an international resistance database.
Data Sources: FDA-CDC-USDA National Antimicrobial Monitoring Program
Baseline Data:
FY 1999: Develop infrastructure.
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 error due to re-keying of data. 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 pre-approval performance measures are appropriate for our stated goals. We are also working with, and using data from, other governmental agencies such as CDC and USDA. We have established memorandums of understanding and memorandums of need with other agencies to ensure that our data needs are addressed by our federal partners. For example, FDA was fully involved in the design and development of the FDA/USDA Residue Violation Information System (RVIS).
Some of our performance measures required the creation of new data bases to capture the appropriate information and track our progress. For example, in order to accomplish our Food Safety Initiative goals we developed some 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 (HACCP) plan, the requirements that slaughter plants sample has changed substantially. USDA's Food Safety Inspection Service (FSIS) 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 data applications in software application. The Animal Drugs and Feeds program has been developed in conjunction with the FDA's program of creating an inventory of data applications, analyzing their degree of Year 2000 compliance, and developing a plan to ensure compliance with Year 2000 requirements.
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.
3. Figures from the National Academy of Sciences.
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