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Department of Health and Human Services
U.S. Food and
Drug Administration
Congressional Justification
FY 2004 Annual Performance Plan
FY 2003 Revised Final Performance Plan
FY 2002 Annual Performance Report
| Goal ID | Original Goal Statement as stated in FY 03 Congressional Justification | Disposition | Revised FY 2003 Targets | Explanation |
|---|---|---|---|---|
| FOODS | ||||
| 11001 | Complete the safety evaluation of 65 percent of the number of food and color additive petitions that were under review for more than 360 days at the beginning of the Fiscal Year. | Revised | Complete review and action on the safety evaluation of 65% of food and color additive petitions within 360 days of receipt. | FDA has changed all its major premarket goals to be consistent agency-wide, and decrease the potential for confusion that is associated with each program's unique terminology. These goals now include the statement "complete review and action onÖ" |
| 11010 | Achieve adoption of the Food Code by at least one state agency in 33 states in the USA. | Unchanged | ||
| 11020 | Inspect 95 percent of high-risk domestic food establishments once every year. | Unchanged | ||
| 11025 | Respond to 95 percent of notifications for dietary supplements containing "new dietary ingredients" within 75 days. | Unchanged | ||
| 11027 | Maintain current level of monitoring for pesticides and environmental contaminants in foods through the collection and analysis of a targeted cohort of 8,000 samples. | Unchanged | ||
| 11034 | Review 95 percent of premarket notifications for food contact substances in the receipt cohort of FY 2002 within the statutory time limit (120 days). | Unchanged | ||
| 11035 | Publish a final rule to require premarket notification for bioengineered foods. | Dropped | This goal has been dropped because developing the final rule will require further intensive analysis focused at least in part on the question of statutory authority as well as elaborating the process, and the decision criteria and endpoints of such a program. These new challenges make this goal unrealistic for the coming fiscal year. | |
| 11036 | Increase the number of physical exams by 100% to 48,000 exams and conduct sample analyses on products with suspect histories. | Unchanged | This goal statement and target are unchanged, however this goal has been repeated in the Agency-wide Program Section that focuses on Global Product Safety and Security to reflect the Agency's coordinated response to terrorist threats. | |
| 11037 | Enhance productivity at the 45 additional ports through focused training. | Dropped | This goal has been dropped because it is not specific enough. It is being replaced with more specific and effective measures starting in FY 04 in the Agency-wide Program Section that focuses on Global Product Safety and Security. | |
| Human Drugs | ||||
| 12001 | Review and act on 90% of standard original NDA submissions within 10 months of receipt and 90% of priority original NDA submissions within 6 months. | Revised | Meet PDUFA III commitments for the review of original NDA submissions. Standard NDAs within 10 months- FY 03: 90%. Priority NDAs within 6 months- FY 03: 90%. | The goal has been revised to incorporate PDUFA III. |
| 12003 | Review and act upon fileable original generic drug applications within 6 months after submission date. | Revised | Complete review and action on fileable original generic drug applications within 6 months after submission date. | FDA has changed all its major premarket goals to be consistent agency-wide, and decrease the potential for confusion that is associated with each program's unique terminology. These goals now include the statement "complete review and action onÖ" |
| 12007 | Streamline adverse drug event reporting system. | Unchanged | ||
| 12016 | CDER will conduct laboratory research on at least three projects identified as related to the mission of PQRI | Unchanged | ||
| 12020 | Inspect registered human drug manufacturers, repackers, relabelers and medical gas repackers. | Revised | Inspect 55% of registered high-risk human drug manufacturers. | The revised goal supports a risk-based approach by encouraging inspections at drug establishments that address or prevent manufacturing problems that would have the most significant adverse effect on drug safety and effectiveness. |
| 12026 | Implement, evaluate, track and report on the clinical trials FDA is requesting under FDAMA or requiring under the Pediatric Rule. | Revised | Increase the number of drugs that are adequately labeled for children. | The revised goal clearly indicates FDA's intent on the behalf of the pediatric population. |
| 12032 | Protect human research subjects who participate in drug studies and assess the quality of data from these studies by conducting approximately 780 onsite inspections and data audits annually. | Revised | Protect human research subjects who participate in drug studies and assess the quality of data from these studies by conducting onsite inspections and data audits annually | Decreasing NDA submissions in FY 2001 and 2002 has necessitated the need to establish new baselines. The number of inspections is dependent on submissions and will fluctuate accordingly. |
| 12036 | Identify and begin to address labeling gaps in the therapeutic armamentarium for the prevention, mitigation, and treatment of illnesses cases by chemical and biological attacks, including the needs for special populations, such as pregnant women, pediatric, and geriatric populations. | Dropped | Replaced by new counter terrorism goal below #12045. | |
| 12037 | Develop guidance for Industry on developing antiviral drugs for the mitigation of complications associated with vaccinia immunization. | Dropped | Replaced by new counter terrorism goal below #12045. | |
| 12038 | Facilitate human clinical trials in pneumonic plague for antimicrobial drugs that are not yet labeled for this treatment indication. | Dropped | Replaced by new counter terrorism goal below #12045. | |
| 12039 | Develop guidance for Industry on developing antiviral drugs for the treatment of smallpox. | Dropped | Replaced by new counter terrorism goal below #12045. | |
| 12041 | Expedite the review of protocols for investigational new radioprotectant drugs (including heavy metal chelators) for use in the event of a radiation emergency. | Dropped | Replaced by new counter terrorism goal below #12045. | |
| 12042 | Finalize rulemaking to establish a web-based electronic drug registration and listing database to allow for complete and up-to-date data on all regulated drug products, and follow this finalization with launch of the electronic database. | Dropped | Combined with re-added goal #12027 below. | |
| 12027 | Re-added | Give consumers and health professionals more easily understandable, accessible, timely, and accurate prescription and OTC drug information. | Was in the performance plan in FY 01, was dropped, re-added, and combined with goal #12042. | |
| 12045 | New | Facilitate development and availability of medical countermeasures to limit the effects of the intentional use of biological, chemical, or radiologic/nuclear agents. | New counter terrorism goal with specific milestones to replace previous counteterrorism goals. | |
| 12051 | New | Create state-of-the-art information management systems and practices to move to a paperless environment (e-Government). | The use of current technology will allow CDER to receive and review regulatory submissions more efficiently. Standards for submission must be developed in order to move to a paperless environment in an efficient and cost effective manner. This goal also falls under the President's Management Agenda of e-government. | |
| Biologics | ||||
| 13001 | Review and act on 90% of standard original PDUFA NDA/PLA/BLA submissions within 10 months; and review and act on 90% of priority original PDUFA NDA/PLA/BLA submissions within 6 months of receipt | Revised | FDA has changed all its major premarket goals to be consistent agency-wide, and decrease the potential for confusion that is associated with each program's unique terminology. These goals now include the statement "complete review and action onÖ" | |
| 13002 | Review and act on 90% of standard PDUFA efficacy supplements within 10 months; and review and act on 90% of priority PDUFA efficacy supplements within 6 months of receipt. | Revised | FDA has changed all its major premarket goals to be consistent agency-wide, and decrease the potential for confusion that is associated with each program's unique terminology. These goals now include the statement "complete review and action onÖ" | |
| 13003 | Review and act on 90% of PDUFA manufacturing supplements within 6 months of receipt, and review and act on 90% of PDUFA manufacturing supplements requiring prior approval within 4 months of receipt. | Revised | FDA has changed all its major premarket goals to be consistent agency-wide, and decrease the potential for confusion that is associated with each program's unique terminology. These goals now include the statement "complete review and action onÖ" | |
| 13004 | Review and act on 90% of Class 1 resubmitted original PDUFA applications within 2 months; and review and act on 90% of Class 2 resubmitted original PDUFA applications within 6 months of receipt. | Revised | FDA has changed all its major premarket goals to be consistent agency-wide, and decrease the potential for confusion that is associated with each program's unique terminology. These goals now include the statement "complete review and action onÖ" | |
| 13005 | Review and act on 90% of complete blood bank and source plasma PLA/BLA submissions, and 90% of PLA/BLA supplements within 12 months after submission date. | Revised | FDA has changed all its major premarket goals to be consistent agency-wide, and decrease the potential for confusion that is associated with each program's unique terminology. These goals now include the statement "complete review and action onÖ" | |
| 13012 | Meet the biennial inspection statutory requirement by inspecting 50% of registered blood banks, source plasma operations and biologics manufacturing establishments. | Unchanged | ||
| 13013 | Expedite review of product specific lot release and extension of dating submissions for the Anthrax Vaccine Absorbed (AVA). | Dropped | Replaced by new counter terrorism goal below #13019 that has more specific milestones. | |
| 13014 | Provided guidance to the CDC, DOD and the Anthrax Vaccine Absorbed manufacturer regarding clinical studies to support proposed changes in the immunization schedule and routes of administration. | Dropped | Replaced by new counter terrorism goal below #13019 that has more specific milestones. | |
| 13015 | Facilitate expedited development and review of new vaccines for protection and/or treatment against bioterrorism related threat diseases (e.g., smallpox and anthrax vaccines). | Dropped | Replaced by new counter terrorism goal below #13019 that has more specific milestones. | |
| 13016 | Facilitate expedited development and review of new gamma globulins for protection and/or treatment against bioterrorism related threat diseases. | Dropped | Replaced by new counter terrorism goal below #13019 that has more specific milestones. | |
| 13017 | Evaluate the need for guidance documents to assist in the development of products such as immunoglobulins and select vaccines. | Dropped | Replaced by new counter terrorism goal below #13019 that has more specific milestones. | |
| 13019 | New | Facilitate the availability of safe and effective biological products to prevent, diagnose, and treat sicknesses or injuries associated with a terrorist attack. | New counter terrorism goal with specific milestones to replace previous counteterrorism goals | |
| Animal Drugs and Feeds | ||||
| 14002 | Continue to pilot and validate procedures to receive protocol submissions electronically. FY 03 Target: Receive protocols and ADE active form. | Revised | Continue electronic submission enhancements.FY 03 Target: Receive and act on protocols forms electronically. | Revised to reflect a more direct goal. Also, since the Adverse Drug Event (ADE) active form is a postmarket function, it was deleted from this premarket performance plan goal/target. |
| 14005 | CY 03 Goal/Target: Maintain isolate testing rate for Salmonella in the National Antimicrobial Resistance Monitoring System (NARMS) at 12,000. | Revised | FY 03 Goal: Enhance the transparency of the NARMS program to stakeholders, the public, and other interested parties by increased reporting and communicating of NARMS results and program information.FY 03 Target: Present NARMS susceptibility testing results at Scientific meetings via poster or oral presentations. Publish Annual Reports of NARMS animal, human and retail meat data. Post NARMS publication references on the website. | This change was presented during the OMB PART Assessment. Previously, the goal reflected dependence on factors beyond FDA's control such as the number of humans contracting a foodborne disease and a change in the type of isolate samples collected by USDA. The goal was revised to reflect how the Animal Drugs and Feeds Program will use NARMS data to communicate with the public on antibiotic resistance. |
| 14006 | Conduct targeted BSE inspections of 100% of all known renderers and feed mills handling prohibited material. | Revised | Conduct targeted BSE inspections of 100% of all known renderers and feed mills processing products containing prohibited material. | This change is to better define the inventory of firms being inspected. The definition now indicates inspections of known renderers and feed mills processing products containing prohibited materials, not just handling products containing prohibited materials. |
| 14007 | Maintain the level of requested pre-submission conferences conducted with industry sponsors at 80% | Dropped | This goal was dropped because the performance is stable, and therefore, no longer provides a useful measurement for Center management. | |
| 14009 | Maintain biennial inspection coverage by inspecting 50% of registered animal drug and feed establishments. | Unchanged | ||
| 14017 | Review and act on 90% of all new animal drug applications and supplements within 275 days and review and act on 90% of all investigational new animal drug data submissions (type P) within 325 days. | Revised | Complete review and action on 90% of all new animal drug applications and supplements received in FY 03 within 275 days and review and act on 90% of all investigational new animal drug submissions received in FY 03 within 325 days. | FDA has changed all its major premarket goals to be consistent agency-wide, and decrease the potential for confusion that is associated with each program's unique terminology. These goals now include the statement "complete review and action onÖ". |
| 14018 | Begin to design and implement a Staff College. 03 Expansion of content and developmental components & integration w/Center & Agency IT infrastructure. | Revised | Continue development, expansion and integration of the Staff College.FY 03 Target: Expand content of in-house programs. Research and develop components and integration of competency-based learning management system (LMS) with Center and Agency IT infrastructure. | Revision provides better detail. |
| 14019 | Reduce pending overdue Animal Drug applications by 15%. | Revised | Reduce pending overdue Animal Drug submissions by 15%. | Clarifying language. |
| Medical Devices | ||||
| 15001 | Review and Complete 95% of Premarket Approval Application (PMA) first actions within 180 days. | Revised | Complete review and action on 90% of Premarket Approval Application of an estimated 80 (PMA) first actions within 180 days. | FDA has changed all its major premarket goals to be consistent agency-wide, and decrease the potential for confusion that is associated with each program's unique terminology. These goals now include the statement "complete review and action onÖ".Dropped to 90% because of the increase of the workload. Added workload information. |
| 15002 | Review and complete 95% of 510(k) (Premarket Notification) first actions within 90 days. | Revised | Complete review and action on 95% of an estimated 4,500 510(k) (Premarket Notification) first actions within 90 days. | FDA has changed all its major premarket goals to be consistent agency-wide, and decrease the potential for confusion that is associated with each program's unique terminology. These goals now include the statement "complete review and action onÖ".Dropped to 90% because of the increase of the workload. Added workload information. |
| 15003 | Recognize 20 new or enhanced standards to use in application review. | Unchanged | ||
| 15005.01 | Provide inspection coverage for Class II and Class Ill domestic medical device manufacturers at 20%. | Revised | Utilize Risk management to target inspection coverage for Class II and Class Ill domestic medical device manufacturers at 20% of estimated 5,300. | Revised by using risk management to target Class II and Class III Ill domestic medical device manufacturers. Added workload information. |
| 15005.02 | Provide inspection coverage for Class II and Class Ill foreign medical device manufacturers at 9% for FY 2003. | Revised | Utilize Risk management to target inspection coverage for Class II and Class Ill foreign medical device manufacturers at 9% of estimated 2,500. | Revised by using risk management to target Class II and Class III Ill domestic medical device manufacturers. Added workload information. |
| 15007 | Ensure at least 97% of mammography facilities meet inspection standards, with less than 3% with Level I (serious) problems. | Revised | Ensure at least 97% of an estimated 8749 domestic mammography facilities meet inspection standards, with less than 3% with Level I (serious) problems. | Added workload information. |
| 15009 | Review and complete 95% of PMA supplement final actions within 180 days. | Revised | Complete review and action on 95% of an estimated 725 PMA supplement final actions within 180 days | FDA has changed all its major premarket goals to be consistent agency-wide, and decrease the potential for confusion that is associated with each program's unique terminology. These goals now include the statement "complete review and action onÖ".Also added workload information |
| 15012 | Implement the MeDSuN System by expanding the network to 180 facilities. | Unchanged | ||
| 15024 | Complete 95% of PMA "Determination" meetings within 30 days. | Unchanged | ||
| 15025 | Conduct 290 BIMO inspections with an emphasis on vulnerable populations (e.g., mentally impaired, pediatric, etc.) | Revised | Conduct 295 BIMO inspections with an emphasis on vulnerable populations (e.g., mentally impaired, pediatric, etc.) | Target increased. |
| 15027 | Provide inspection and product testing coverage of Radiological Health industry at 10% | Revised | Maintain inspection and product testing coverage of Radiological Health industry at 10% of an estimated 2000 electronic products. | Revised to maintain inspection to reflect more specific performance target in the goal statement. |
| 15028 | Expedite review for 100% of Bioterrorism Diagnostic Medical Device Applications. | Revised | Expedite review for 100% of an estimated 5 Bioterrorism Diagnostic Medical Device Applications. | Added workload information |
| 15029 | Implement Emergency Counter Terrorism Preparedness and Response Plan for radiation. | Unchanged | ||
| 15030 | Begin to develop radiation standards for the safety of novel or new technology used to scan people in airports and other places. | Unchanged | ||
| NCTR | ||||
| 16001 | Introduce the knowledge of new genetic systems and computer-assisted toxicology (bioinformatics) into the application review process. | Revised | Introduce the knowledge of new genetic systems and computer-assisted toxicology (toxicoinformatics) into the risk management process. | To enhance FDA's risk management process. |
| 16002 | Develop, with other organizations, gene chip and gene array technology. | Unchanged | ||
| 16003 | Develop computer-based models and infrastructure to predict the health impact of increased exposure to estrogens and anti-estrogen compounds. | Revised | Develop computer-based models and infrastructure to predict the health risk of biologically active products | To broaden FDA's ability to evaluate risks associated with regulated products. |
| 16004 | Study FDA-regulated compounds to relate the mechanism(s) by which a chemical causes toxicity. | Revised | Study the risk associated with how a FDA regulated compound or product interacts with the human body. | To broaden FDA's ability to evaluate risks associated with regulated products. |
| 16007 | Develop methods and build biological dose-response models to replicate bacterial survival in the stomach. | Revised | Develop risk assessment methods and build biological dose-response models in support of the Food Safety Initiative. | To broaden FDA's risk assessment methods to ensure a safe food supply. |
| 16012 | Catalogue biomarkers and develop standards to establish safety and effectiveness of imaging devices for potential use in the diagnosis of toxicity. | Revised | Catalogue biomarkers and develop standards to establish risk in a bioterrorism environment | Focus research efforts to support FDA's counter-terrorism efforts. |
| 16013 | Use new technologies (bioinformatics, imaging, proteomics, and metabonomics) for diagnosis of toxicity. | Revised | Use new technologies (bioinformatics, imaging, proteomics, and metabonomics) for diagnosis of risk. | To broaden FDA's ability to evaluate risks associated with regulated products. |
| Agency Wide | ||||
| 19001 | Increase supervisory ratio to increase the span of control among management personnel. | Reduce the number of review levels in the Agency to help streamline operations. Develop and implement a plan to delayer CBER, CFSAN and ORA; Transfer Legislative and Public Affairs function to DHHS | Revised | The attempt was made to incorporate language from the Booze Allen study and bring the goal more in sync with the consolidation idea. |
| 19002 | Consolidate administrative functions in the agency. | Revised | Implement 'shared services' concept and consolidate selected functions in the agency. Personnel, Finance, Budget, Procurement, Grants, Information Technology, Legislative & Public Affairs. Begin implementation of shared services concept in accordance with the BAH Administrative Consolidation Study. | The attempt was made to incorporate language from the Booze Allen study and bring the goal more in sync with the consolidation idea. |
| 19003 | Increase the percentage of Commercial FTE that will be reviewed for outsourcing. | Unchanged | ||
| 19004 | Increase the percentage of electronically purchased transactions.* | Unchanged | ||
| 19005 | Maintain a clean (or unqualified) audit opinion with no material weakness. | Unchanged | ||
| 19006 | Increase percentage of contract dollars to performance based contracts from 30 percent. | Unchanged | ||
| 19007 | Assure continuity of FDA operations in case of an emergency. | Dropped | Goal is essentially completed and only requires maintenance. | |
| 19010 | New | Expand the Agency-wide IT security program to ensure all of Agency's IT assets that support the Agency's business processes are in compliance with the Government Information Security Reform Act (GISRA). Assess OC, NCTR and selected other critical components for GISRA compliance, and resolve any access control issues. | Goal was included to bring the agency into compliance with the GISRA and to generally protect information and prevent waste, fraud, and abuse. | |
| 19017 | New | Begin implementation of a new financial system. Financial Business Solutions at FDA. | To bring the agency into compliance with HHS's new financial system | |
| 19015 | New | Perform at least 1,000 Filer Evaluations under new procedures. | The combination of new hires and a shift to a more risk based approach to ensuring public education and safety has allowed FDA to add this goal. | |
| 19016 | New | Conduct 2,000 examinations of FDA refused entries as they are delivered for exportation to ensure that the articles refused by FDA are being exported. | The combination of new hires and a shift to a more risk based approach to ensuring public education and safety has allowed FDA to add this goal to move one step closer to ensuring that refused articles are being exported. | |
| 19013 | New | Expand federal/state/local involvement in FDA's eLEXNET system by having 79 laboratories participate in the system. 54 laboratories participating in eLEXNET in 2003. | New technologies have allowed FDA to apply a more effective risk-based approach to ensuring the safety of foods and working with other agencies. | |
| 19008 | New | Enhance the Agency Emergency Preparedness Plan to establish protocols for responding to terrorist attacks. | FDA has added this goal to help better prepare the agency and it's individual programs to respond more efficiently to emergencies. | |
| 19014 | Revised | Perform 48,000 physical exams and conduct sample analyses on products with suspect histories. Increase exams by 100 % to 48,000 exams | Copied from Foods section to the agency wide. Previously goal # 11036 | |
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