Changes and Improvement over Previous Years
Disposition of FY 2006 Performance Goals
|Goal ID||Original Goal Statement as
stated in FY 06 Congressional Justification
|Disposition||Revised FY 2006 Targets||Explanation|
Center for Food Safety and Applied Nutrition
|11001||Provide premarket reviews within statutory time frames to assure the safety of food ingredients, bioengineered foods and dietary supplements. Measure: Complete review and action on the safety evaluation of 75% of food and color additive petitions within 360 days of receipt||Revised||Complete review and action on the safety evaluation of 70% of food and color additive petitions within 360 days of receipt||Target reduced due to strategic redeployement of resources to highest priority areas.|
|11010||Increase risk management strategies and communication to government, industry and consumers in order to ensure the safety of the nation's food supply. Measure: Increase the percentage of the U.S. population that will live in states that have adopted the Food Code to 49 States/ 84%||Unchanged|
|11040||Perform prior notice import security reviews on 38,000 food and animal feed line entries considered to be at high risk for bioterrorism and/or present the potential of a significant health risk.||Revised||The target has been revised upward now that ORA has a complete year of experience in conducting prior notice activities.|
|11036||Perform 60,000 import food field exams on products with suspect histories.||Revised||Perform 73,376 import food field exams on products with suspect histories.||We have observed increased numbers of import food field exams in FY 2005 and expect that attrition will not be reflected until FY 2007. It is possible that more field exams are being performed in FY 2005 because travel funds are not available to fund inspections and other activities. The lack of travel funds will play a role in the FY 2006 activities.|
|19015||Perform at least 1,000 Filer Evaluations under new procedures.||Revised||Perform 965 Filer Evaluations of Import Filers.||The target has been reduced to reflect the impact of the 2005 natural disasters in the Southeastern U.S. on FDA operations.|
|19016||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.||Revised||Conduct 2,992 examinations of FDA refused entries as they are delivered for exportation to ensure that the articles refused by FDA are being exported.||The target was increased because in FY 2004, the first year of performance under this goal, the actual performance was higher than originally estimated.|
|11020||Conduct postmarket monitoring, food surveillance, inspection, and enforcement activities to reduce health risks associated with food, cosmetics and dietary supplements products. Measure: Inspect 95% of estimated 6,800 high-risk domestic food establishments once every year.||Revised||
Conduct postmarket monitoring, food surveillance, inspection, and enforcement activities to reduce health risks associated with food, cosmetics and dietary supplements products.
Measure: Inspect 5,963 high-risk domestic food establishments.
|The target has been reduced to reflect the impact of the 2005 natural disasters in the Southeastern U.S. on FDA operations.|
|19013||Expand federal/state/local involvement in FDA's eLEXNET system by having 105 laboratories submit data in the system.||Unchanged|
Establish and maintain a quality system in the ORA Field Labs which meets the requirements of ISO 17025 (American Society for Crime Lab Directors for the Forensic Chemistry Center) and obtain accreditation by an internationally recognized accrediting body (American Association for Laboratory Accreditation). Measure: Achieve and maintain accreditation for 13 laboratories.
Center for Drug Evaluation and Research
Improve the efficiency and effectiveness of the new drug review program to ensure a safe and effective drug supply is available. Measure:
Meet PDUFA III commitments for the review of original NDA submissions by including:
Standard NDAs within 10 months: FY 06: 90% and Priority NDAs within 6 months:
FY 06: 90%
|12026||Increase the number of drugs that are adequately labeled for children and ensure the surveillance of adverse events in the pediatric population. Measure: Issue at least 10 written requests (WRs) for drugs that need to be studied in the pediatric population and report to the pediatric advisory committee on adverse events for at least 10 drugs that receive pediatric exclusivity.||Unchanged|
|12003||Improve the efficiency and effectiveness of the generic drug review program to ensure safer and more effective generic drug products are available for Americans. Measure: Decrease the average FDA time to approval or tentative approval for the fastest 70% of original generic drugs applications by 0.5 months.||Revised||Measure: Decrease the average FDA time to approval or tentative approval for the fastest 25% of original generic drugs applications by 0.5 months.||Target reduced due to strategic redeployement of resources to highest priority areas.|
|12048||Improve the efficiency and effectiveness of the over-the-counter (OTC) drug review program to ensure a safe and effective drug supply is available. Measure: Complete review and action on 100% of Rx-to-OTC Switch applications within 10 months of receipt. Make significant progress on completing 6 OTC monographs.||Unchanged|
|12045||Enhance the protection of the American public against the effects of terrorist agents by facilitating the development of and access to medical countermeasures, providing follow-up assessments on therapies, and engaging in emergency preparedness and response activities. Measure: Coordinate and facilitate development for at least 6 medical countermeasures.||Unchanged|
|12007||Improve the Safe Use of Drugs in Patients and Consumers. Measure: Review and provide comments on 100% of Risk Minimization Action Plans (RiskMAPs) for NMEs and for those products for which the sponsor or FDA initiated discussions, in accordance with applicable PDUFA goal dates.||Revised||Measure: Standardize Agency processes and criteria for communicating risk information to patients and healthcare providers.||Targets are being incrementally revised to bring the goal closer to an outcome goal.|
|12020||Increase risk-based compliance and enforcement activities to ensure product quality. Measure: Inspect 65% of the establishments identified as high-risk.||Revised||
Increase risk-based compliance and enforcement activities to ensure drug product quality.
Measure: The number of inspections conducted of domestic establishments identified as high-risk human drug manufacturers.
|Given the fluctuation in the inventory, the inspection resources available, and the risk-based prioritization approach that FDA is developing, we believe that it is more appropriate to state the goal in terms of the number of inspections of the highest-risk establishments.|
Center for Biologic Evaluation and Research
|13001||Complete review and action on 90% of standard original PDUFA NDA/BLA submissions within 10 months; and review and act on 90% of priority original PDUFA NDA/BLA submissions within 6 months of receipt.||Unchanged|
|13002||Complete review and action 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.||
|13005||Complete review and action on 90% of complete blood bank and source plasma BLA submissions, and 90% of BLA supplements within 12 months after submission date.||Unchanged|
Increase manufacturing diversity and capacity for pandemic influenza vaccine production through interacting with vaccine researchers and developers and issuing guidance and other documents and through global vaccine response coordination to facilitate the development and expedite the evaluation of cell-based technologies and dose-sparing approaches, such as the use of adjuvants.
Develop a concept paper on clinical data needed to support license of new trivalent vaccines and of pandemic vaccines; draft a guidance on cell substrates to facilitate development of non-egg-based influenza vaccines; co-sponsor two workshops with WHO on pandemic vaccines.
|This goal was added to account for the increase in resources received for pandemic flu. In order to assess progress towards goal attainment, targets were selected that were directly related to the strategies that will be implemented.|
|13012||Meet the biennial inspection statutory requirement by inspecting 50% of the approximately 2,600 registered blood banks, source plasma operations and biologics manufacturing establishments to reduce the risk of product contamination.||Revised||
Increase risk-based compliance and enforcement activities by inspecting the highest-risk registered blood banks, source plasma operations and biologics manufacturing establishments to reduce the risk of product contamination; and by conducting human tissue inspections to enforce the new regulations.
Measure: The number of inspections (1,128) conducted of the highest-risk registered blood banks, source plasma operations and biologics manufacturing establishments.
Measure: The number of human tissue inspections (250) conducted to enforce the new regulations.
A new measure was added to this goal to
Center for Veterinary Medicine
Promote safe and effective animal drug availability ensuring public and animal health by meeting ADUFA performance goals.
Measure: Complete review and action on 90% of original NADAs and reactivations of such applications received in FY 2006 within 230 days.
|14009||Ensure the safety of marketed animal drugs and animal feeds by conducting appropriate and effective surveillance and monitoring activities. Measure: Maintain biennial inspection coverage by inspecting 50% of 1,390 registered animal drug and feed establishments; and conduct targeted BSE inspections of 100% of all known renderers and feed mills processing products containing prohibited material.||Revised||
Ensure the safety of marketed animal drugs and animal feeds by conducting appropriate and effective surveillance and monitoring activities.
Measure: The number of inspections (618) conducted of registered animal drug and feed establishments.
Measure: The number of targeted BSE inspections (527) conducted of all known renderers, protein blenders, and feed mills processing products containing prohibited material.
|This goal is revised to state the goal in terms of the number of inspections. The number of facilities is continuing to show a downward trend.|
Center for Devices and Radiological Health
|15033||Complete Review and Decision on 80% of Expedited PMAs within 300 days.||Revised||
Percentage of Expedited PMAs reviewed and decided upon within 300 days; Percentage of received Original Premarket Approval (PMA), Panel-track PMA Supplement, and Premarket Report Submissions reviewed and decided upon within 320 days./1
Measure 1A: Percentage of Expedited PMAs reviewed and decided upon within 300 days
Measure 1B: Percentage of received Original Premarket Approval (PMA), Panel-track PMA Supplement, and Premarket Report Submissions reviewed and decided upon within 320 days./1
|Measure 1B was added|
|15032||Complete Review and Decision on 75% of 510(k)s (Premarket Notifications) within 90 days||Revised||Percentage of 510 (k)s (Premarket Notifications) reviewed and decided upon within 90 days./1||Separated goal statement from the measure.|
|15027||Maintain inspection and product testing coverage of Radiological Health industry at 10% of an estimated 2000 electronic products.||Dropped||Goal has been dropped in order to streamline the Performance Plan.|
|15007||Ensure at least 97% of an estimated 9,100 domestic mammography facilities meet inspection standards, with less than 3% with Level I (serious) problems.||Revised||Percentage of an estimated 9,100 domestic mammography facilities that meet inspection standards, with less than 3% with Level I (serious) problems||Separated goal statement from the measure.|
|15012||Expand implementation of MedSun to a network of 350 facilities. Measure: Maintain a cohort of 350. Roll-out non-performers and replace with new sites to maintain the 350.||Revised||Expand actively participating sites in the MedSun Network to 71%.||Expansion of the network to the total target number of sites specified in the initiative will be achieved in FY 2005. In FY 2006, FDA will change its focus to increasing the number of active facilities.|
|15025||Conduct 295 domestic and foreign BIMO inspections with an emphasis on scientific misconduct, data integrity, innovative products, and vulnerable populations.||Revised||Conduct 278 domestic and foreign BIMO inspections with an emphasis on scientific misconduct, data integrity, innovative products, and vulnerable populations.||The target has been reduced to reflect the impact of the 2005 natural disasters in the Southeastern U.S. on FDA operations.|
|15005.01||Utilize Risk management to target inspection coverage for Class II and Class Ill domestic medical device manufacturers at 20% of an estimated 5,540 firms.||Revised||Utilize risk management to target inspection coverage for Class II and Class III medical device manufacturers (domestic and foreign).||The Medical Device domestic inspection goal and the foreign inspection goal have been combined into one overall risk-based goal in order to continue our progress towards risk-based inspection measures.|
|15005.02||Utilize Risk management to target inspection coverage for Class II and Class Ill foreign medical device manufacturers at 7% of an estimated 2,500 firms.||Dropped||The FY 2006 and FY 2007 targets have been dropped for this goal. In FY 2006 and beyond, these inspections will be included in goal 15005.01 above.|
National Center for Toxicological Research
|16014||Use new technologies (toxicoinformatics, proteomics, metabolomics, and genomics) to study the risk associated with how an FDA-regulated compound or product interacts with the human body. Measure: Present one finding utilizing novel technologies to assess changes in genes and pathology, and the relationship between chemical exposure, toxicity and disease.||Unchanged|
|16003||Develop computer-based models and infrastructure to predict the health risk of biologically active products. Measure: Interpret at least one toxicology study at the molecular level utilizing the DNA microarray database (ArrayTrack).||Unchanged|
|16007||Develop risk assessment methods and build biological dose-response models in support of Food Security. Measure: Demonstrate one utility of an oligonucleotide-microarray method as an integrated strategy to respond to antibiotic resistant agents in foodborne pathogens and bioterror agents.||Unchanged|
|16012||Catalogue biomarkers and develop standards to establish risk in a bioterrorism environment. Measure: Present one finding utilizing neuropathology and behavioral risk evaluation in the prediction of human outcome to food-borne toxicants.||Unchanged|
|19006||Maintain 50% percentage of contract dollars allocated to performance based contracts||Dropped||FDA routinely meets or exceeds this goal. The targets for FY 2006 and FY 2007 have been dropped.|
|19017||FDA's implementation of HHS's Unified Financial Management System. Measure: FDA will pilot an activity-based costing application integrated with HHS UFMS project as part of Prescription Drug User Fee Act III.The UFMS and its FDA modules will be operational in FY05 allowing FDA's legacy system core financial system to be decommissioned during the first quarter of FY 2006||Unchanged|
|19008||Enhance the Agency Emergency preparedness and response capabilities to be better able to respond in the event of a terrorist attack. Measure: Enhance functionality and continue deployment of the National Incident Management System throughout the Agency (HQ, Centers, Field offices).||Unchanged|