Note: This list excludes FY 1999 goals added after January 1998. For a complete list of FY 1999 goals see Appendix 2: FY 1999 and FY 2000 FDA Performance Plan Summary
| Original Goal Statement1 | Disposition | Revised Goal | Explanation | |
| Foods | ||||
| 11001 | By the end of FY 1999, complete reviews of 30% of food and color additive petitions within 360 days. | Revised | Complete first action (i.e., review all parts of the petition and issue a "not approvable" letter, or publish a response in the Federal Register, if appropriate) on 30 percent of food and color additive petitions within 360 days of receipt. | Revised to be consistent with FY2000 performance goal on petition reviews. |
| 11002 | By the end of FY 1999, reduce the number of overdue food and color additive petitions to 30% of those petitions under review. | Revised | By the end of FY 1999, reduce the percentage of overdue food and color additive petitions (i.e., under review for more than 360 days) to 30 percent of those petitions under review. | Revised to be consistent with FY2000 performance goal. |
| 11003 | During FY 1999, finalize the rulemaking creating a premarket notification process for independent generally recognized as safe (GRAS) determinations. | Unchanged | ||
| 11004 | By 12/30/99, 50% of the seafood industry will be operating preventive controls for safety as evidenced by functioning, appropriate HACCP systems. | Revised | By 12/30/99, 50% of the domestic seafood industry will be operating preventive controls for safety as evidenced by functioning HACCP systems. | Revised to be consistent with FY2000 performance goal. |
| 11005 | Increase the percentage of domestic produce produced consistent with voluntary good agricultural practices (GAP)/good manufacturing practices (GMP) broadscope guidance to reduce microbial contamination. | Unchanged | ||
| 11006 | During FY 1999, take steps to implement the HACCP regulation for the juice industry, including providing training, technical assistance and guidance to industry and states. | Revised | During FY 1999, develop HACCP final rule for fruit and vegetable juices. | Change in FY 1999 Appropriation level from funding levels in President's Budget. |
| 11007 | By the end of FY 1999, increase to at least 77% the proportion of people aged 18 and over who use food labels to make nutritious food selections. | Unchanged | ||
| 11008 | During FY 1999, work with the Centers for Disease Control and Prevention (CDC) and other Federal agencies to develop baseline surveillance data on foodborne illnesses required to evaluate the effectiveness of, set better priorities for, and determine appropriate outcomes for the Food Safety Initiative. | Unchanged | ||
| 11009 | By the end of FY 1999, improve public access to timely information on adverse events related to dietary supplement products, infant formulas, and medical foods by increasing the frequency of public releases of information in the Special Nutritional Adverse Events Monitoring System (SN/AEMS) from 2 per year to 4 per year. | Unchanged | ||
| 11010 | By the end of FY 1999, enhance the safety of the nation's food supply by achieving adoption of the Food Code by 25% of the states. | Unchanged | ||
| 11011 | Assure that FDA inspections of domestic food manufacturing establishments, in conjunction with the timely correction of serious deficiencies identified in these inspections, result in a high rate of conformance (at least 90%) with FDA requirements by the end of the fiscal year. | Unchanged | ||
| 11012 | Implement a multi-year research plan to develop and improve methods for the detection, control and prevention of microbial contamination on fresh produce and evaluate the effectiveness of technologies for eliminating this contamination. | Unchanged | ||
| 11013 | During FY 1999, develop modeling techniques for assessing human exposure to a variety of foodborne pathogens and for describing low dose infectivity rates for infectious and toxicoinfectious microorganisms. | Unchanged | ||
| 11014 | During FY 1999, work with industry and academia to develop new techniques for eliminating pathogens on fresh produce where traditional thermal processing systems used for processed foods cause fresh produce to deteriorate and become inedible. | Revised | During FY 1999, work with industry and academia to develop new techniques for eliminating pathogens on sprouts and in citrus juice and apple cider. | Change in FY 1999 Appropriation from funding levels in President's Budget. |
| 11015 | During FY 1999, conduct studies on factors that cause foodborne pathogens to develop multiple antibiotic resistance and resistance to traditional food preservation techniques and factors that prevent the development of such resistance. | Unchanged | ||
| 11016 | Use educational campaigns and activities to reduce the prevalence of reported risky food consumption behavior, reduce the prevalence of reported risky food preparation/handling practices, and increase the percentage of people who report using thermometers to assure the safety of foods during cooking. | Revised | Use educational campaigns and activities to reduce the prevalence of reported risky food consumption behavior, reduce the prevalence of reported risky food preparation/handling practices, and document the occurrence of food service behaviors, actions, and conditions that fall into the CDC-identified risk factor categories classified as "contributing factors to foodborne illness outbreaks." | Restated to more clearly express the focus of the goal. |
| 11017 | During FY 1999, increase the safety of imported foods through participation in international standard setting organizations (such as Codex Alimentarius of the United Nations World Health Organization (WHO) and the Food and Agricultural Organization (FAO), the North American Free Trade Agreement's (NAFTA) Standard Phytosanitary Committee, and the World Trade Organization (WTO)) that consider or establish international standards for food safety and sanitation. | Revised | During FY 1999, increase the safety of imported foods through participation in international standard setting organizations and the negotiations of the free trade agreement of the Americas to ensure and international food safety standards are science-based and properly used. | Change in FY 1999 appropriation from funding levels in the President's Budget. |
| Human Drugs | ||||
| Original Goal Statement1 | Disposition | Revised Goal | Explanation | |
| 12002 | Review and act on 90% of complete NDA applications resubmitted following receipt of a non-approval letter, within six months after resubmission date. | Unchanged | ||
| 12003 | Review and act upon 60% of fileable original generic drug applications within six months after submission date. | Unchanged | ||
| 12004 | Review and act upon 90% of standard efficacy supplements within 12 months (30% within 10 months of receipt) and priority efficacy supplements filed within six months of receipt. | Unchanged | ||
| 12005 | Review and act upon 90% of manufacturing supplements within six months and act on 30% of manufacturing supplements requiring prior approval within four months. | Unchanged | ||
| 12006 | Assure the FDA inspections of domestic drug manufacturing and repacking establishments, in conjunction with the timely correction of serious deficiencies identified in these inspections, result in a high rate of conformance (at least 90%) with FDA requirements by the end of the fiscal year. | Unchanged | ||
| 12007 | Implement the Adverse Events Reporting System (AERS) for the electronic receipt and review of voluntary and mandatory ADE reports. | Unchanged | ||
| 12008 | Establish the capability and capacity to receive and archive Abbreviated New Drug Applications (ANDAs) submitted electronically. | Revised | Continue to achieve capability and capacity for electronic submission and archiving of information required to submit new drug applications (NDAs), abbreviated new drug applications (ANDAs) | Regarding Abbreviated Antibiotic Drug Applications (AADAs), FDAMA eliminated the AADAs as a separate submission type. All existing AADAs were converted to Drug Master Files (DMF) and future submissions will come in as DMFs. DMFs are planned for electronic receipt, storage, and archive by the end of FY 2002. |
| 12009 | FDA will: (a) evaluate the availability, quality and usefulness of prescription drug information provided to 75% of individuals receiving new prescriptions; and (b) complete two studies that will aid in development of comprehensive drug information. | Unchanged | ||
| 12010 | FDA will continue to improve the legibility and clarity of OTC drug labels, and improve the consumer's ability to read and understand important warnings and usage directions. | Unchanged | ||
| Biologics | ||||
| Original Goal Statement1 | Disposition | Revised Goal | Explanation | |
| 13001 | Review and act on 90% of standard New Drug Applications (NDA) and Product License Applications/ Biologics License Applications (PLA/BLA) filed within 12 months after receipt (30% within 10 months of receipt); and review and act on 90% of priority NDA and PLA/BLA submissions within six months of receipt. | Unchanged | ||
| 13002 | Review and act on 90% of standard efficacy supplements within 12 months of receipt (30% within 10 months of receipt); and review and act on 90% of priority efficacy supplements within six months of receipt. | Unchanged | ||
| 13003 | Review and act on 90% of manufacturing supplements filed within six months of receipt, and review and act on 30% of manufacturing supplements requiring prior approval within four months of receipt. | Unchanged | ||
| 13004 | Review and act on 90% of Class 1 resubmitted original applications within four months of receipt (50% within two months of receipt); and review and act on 90% of Class 2 resubmitted original applications within six months of receipt. | Unchanged | ||
| 13005 | Review and act on 70% of complete blood bank and source plasma PLA/BLA submissions and PLA/BLA Major supplements within 12 months after submission date. | Revised | Review and act on 60% of complete blood bank and source plasma PLA/BLA submissions and 90% of PLA/BLA Major supplements within 12 months after submission date. | Revised to be consistent with FY2000 performance goal; diversion of resources required and resource cuts in FY99. |
| 13006 | Review and act on 60% of complete blood bank/source plasma Establishment License Applications (ELA) Major supplements within 12 months after submission date. | Dropped | Establishment License Applications (ELAs) and ELA supplements are being phased out with the adoption of the Biologics License Application (BLA), which will replace the Product License Application (PLA) and ELA. The Goal was not included in the FY 2000 plan. | |
| 13007 | Assure that FDA inspections of domestic biologics manufacturers and repacking establishments, in conjunction with the timely correction of serious deficiencies identified in these inspections, result in a high rate of conformance (at least 90%) with FDA requirements by the end of the fiscal year. | Unchanged | ||
| 13008 | Increase the percentage of plasma fractionator establishments in compliance with current good manufacturing practices (CGMPs) to 80 percent. | Revised | Increase the percentage of plasma fractionator Establishments in compliance with Current Good Manufacturing Practices (CGMPs) to 70 percent. | FY 1997 and FY 1998 actual performance lower: change in FY 1999 and in subsequent target levels |
| Animal Drugs and Feeds | ||||
| Original Goal Statement1 | Disposition | Revised Goal | Explanation | |
| 14001 | Improve application processing by implementing ADAA legislation and CVM REGO initiatives, including the Veterinary Feed Directive (VFD),by establishing and/or revising regulations and guidance documents. | Unchanged | ||
| 14002 | Improve application processing time by implementing electronic submission for key components of the investigational new animal drug application process. | Unchanged | ||
| 14003 | Increase the number of antimicrobial product risk assessments by 10% in order to increase the assurance that food derived from animals and animal products is safe for human consumption. | Unchanged | ||
| 14004 | Assure that FDA inspections of domestic animal drug and feed manufacturing establishments, in conjunction with the timely corrections of serious deficiencies identified in these inspections, result in a high rate of conformance (at least 90%) with FDA requirements by the end of the fiscal year. | Unchanged | ||
| 14005 | Assure that food derived from animals and animal products is safe for human consumption by increasing the number of human and animal isolates in the National Antimicrobial Monitoring Program database. | Revised | 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 | More specific targets |
| 14006 | 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. | Unchanged | ||
| Medical Devices and Radiological Health | ||||
| Original Goal Statement1 | Disposition | Revised Goal | Explanation | |
| 15001 | Complete 50% of PMA first actions within 180 days. | Revised | Maintain the on-time percentage of Premarket Approval Application (PMA) first actions (within 180 days) and Humanitarian Device Exemption (HDE) first actions (within 75 days) completed at 65 percent. | Better baseline data; funding change |
| 15002 | Complete 90% of 510(k) first actions within 90 days. Expand third party 510(k) reviews and complete FDA action on 55% of them within 30 days. | Revised | Review and complete 90 percent of 510(k) first actions within 90 days. Expand third party 510(k) reviews and complete FDA action on 75% of them within 30 days. | Better baseline data |
| 15003 | Recognize over 50 standards for use in application review and update the list of recognized standards. | Revised | Recognize over 415 standards for use in application review and update the list of recognized standards. | Better baseline data |
| 15004 | Double the number of low-risk postmarket reports received and processed in summary form. The total number of summary reports will be increased from 25,000 in FY 1998 to over 60,000 in FY 1999. This will be done by shifting postmarket reporting from a paper-intensive individual report system (receiving over 100,000 reports in FY 1996) to an alternate almost entirely electronic reporting system, yielding higher quality information using innovative surveillance methodology like auto screen and developing variances candidates. | Revised | Increase the number of low-risk postmarket reports received and processed in summary form. The total number of summary reports will be increased from 20,000 in FY 1998 to over 25,000 in FY 1999. This will be done using innovative surveillance methods and improving quality and analysis needed for Safety Alerts and other actions. | Funding reduced |
| 15005.01 | Improve the quality conformance of high-risk products like cardiovascular devices by redirecting FDA compliance priorities toward higher-risk devices. | Revised | Improve the quality conformance of high-risk products like cardiovascular devices by committing over 75% of inspection resources to high-risk devices. | Goal focused to measure specific resource investment. |
| 15007 | At least 97% of mammography centers meet key inspection standards, with less than 3% of facilities with Level I (serious) inspection problems. | Revised | Ensure that at least 97 percent of mammography facilities meet inspection standards, with less than 3 percent of facilities with Level I (serious) inspection problems. | Minor editorial changes. |
| 15008 | Improve response to significant risk electronic product radiation noncompliance by initiating regulatory actions and recalls for 95% of identified high-risk noncompliant or defective products within 30 days of discovery. | Revised | Maintain response to significant electronic product risk by initiating regulatory actions and recalls for 95 percent of identified high-risk, noncompliant or defective products within 30 days of discovery. | Minor editorial changes. |
| 15018 | Assure that FDA inspections of domestic medical device manufacturing establishments, in conjunction with the timely correction of serious deficiencies indentified in these inspections, result in a high rate of conformance (at least 95%) with FDA requirements by the end of the fiscal year. | Revised | Assure that FDA inspections of domestic medical device manufacturing establishments, in conjunction with the timely correction of serious deficiencies identified in these inspections, result in a high rate of conformance (at least 90 percent) with FDA requirements. | Reduced funding required lowering target level. |
| National Center for Toxicological Research | ||||
| Original Goal Statement1 | Disposition | Revised Goal | Explanation | |
| 16001 | Demonstrate a model toxicity knowledge base to support and expedite product review. | Unchanged | ||
| 16002 | Develop better biological assays to measure genetic changes and predict human genetic damage. | Unchanged | ||
| 16003 | Complete biochemical and epidemiology studies to define the basis of susceptibility of humans to the toxicity of regulated products. | Unchanged | ||
| 16004 | Develop modeling tools to predict better risk for cancer, reproductive, developmental, neurological, genetic, and acute toxicological outcomes. | Unchanged | ||
| 16005 | Support product review by developing faster, more accurate tests based on mechanisms of toxic actions. | Unchanged | ||
| 16006 | Develop rapid and sensitive methods for identifying pathogens, foodborne bacteria, and microbial contaminants. | Unchanged | ||
| Tobacco | ||||
| Original Goal Statement1 | Disposition | Revised Goal | Explanation | |
| 17001 | Enter into contracts with all 50 states (depending on their willingness) to conduct an average of 42,000 unannounced compliance checks each month of retail establishments that sell tobacco products. each month of retail establishments that sell tobacco products. | Revised | Enter into contracts with all 50 states (or establish a federal investigatory force in those states which are unable or unwilling to contract with FDA), to conduct an average of 16,500 unannounced compliance checks | Funding level reduced. |
| 17002 | Conduct meetings and a multimedia campaign, including point-of-purchase, radio, outdoor advertising, and newspapers, to educate retailers and other stakeholders about their obligations under the FDA tobacco rules and the impact of the rules. Distribute at least 100,000 brochures and fact sheets to retailers on request. | Revised | Conduct meetings and a multimedia campaign, including point-of-purchase, radio, outdoor advertising, and newspapers, to educate retailers and other stakeholders about their obligations under the FDA tobacco rules and the impact of the rules. | Funding level reduced; scope of goal reduced accordingly. |
| 17003 |
Design and, to the fullest extent permitted under any
court orders addressing such activities, begin to
implement a regulatory program for cigarettes and
smokeless tobacco products, including:
- Begin to examine the appropriate scientific and regulatory framework to evaluate products that state or imply that they are less hazardous; - Assist other agencies within the Department of Health and Human Services in providing the Federal Trade Commission with an analysis of the public health issues associated with the testing and reporting of the tar and nicotine content of the smoke of cigarettes; and - Establish an evaluation and review procedure for new products. |
Dropped | No funding. | |
| Imports | ||||
| Original Goal Statement1 | Disposition | Revised Goal | Explanation | |
| 18001 | Accept at least 20% of imports into the U.S. market through evidence of equivalent source country quality systems/standards/audits. | Dropped | International trade agreements with foreign nations are at various stages of development. Definitions of 'equivalence' must first be determined before baseline data for this goal can be developed. | |
| 18002 | Enhance import screening capabilities for public health while ensuring that 55% of entries are released within 15 minutes. | Revised | Complete design specifications for an analysis that is efficiency to a determination of risk-based screening criteria for import entries. | Strategy has shifted from measures of system intended to profile variations in criteria used by different FDA programs in screening import entries. |
| 18003 | Assess potentially violative imports through direct examination of 3% of entries. | Dropped | Strategic emphasis has shifted to prevent activites at the source of production and development of risk. Small percentages of potentially high-risk products will still be directly examined. | |
| External Leverage | ||||
| Original Goal Statement1 | Disposition | Revised Goal | Explanation | |
| 19001 | Expand the system of State Partnership Agreements to comprise at least one per state to increase both quality and efficiency between the Federal, state, and local officials. | Dropped | Not outcome-oriented | |
| 19002 | Publicize and conduct 75 workshops for regulated industry coordinated and/or sponsored by the FDA field offices focusing on providing Agency-wide product line training that results in increased compliance and consumer protection. | Dropped | Not outcome-oriented | |
| 19003 | Correct a majority of significant problems identified in manufacturing/processing operations via prompt, cooperative action. | Dropped | Not outcome oriented; concept included in program conformance goals | |
1. As shown in FY 1999 Congressional Justification
Next: Appendix 2 | Back to Table of Contents