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Disposition of FY 2005 Performance Goals

<< Return to FY 2006 Budget Summary

 

Goal ID Original Goal Statement as stated in FY 05 Congressional Justification Disposition Revised FY 2005 Targets Explanation

Center for Food Safety and Applied Nutrition

11001 Complete review and action on the safety evaluation of 75% of food and color additive petitions within 360 days of receipt. Revised Provide premarket reviews within statutory time frames to assure the safety of food ingredients, bioengineered foods and dietary supplements. (Target: Complete review and action on the safety evaluation of 75% of food and color additive petitions within 360 days of receipt.) New overall goal statement added; target the same
11025 Respond to 95% of notifications for dietary supplements containing “new dietary ingredients” within 75 days. Dropped   This goal will be included in expanded premarket goal (11001) to better allocate full costs.
11010 Increase the percentage of the U.S. population that will live in states that have adopted the Food Code.

Revised

Increase risk management strategies and communication to government, industry and consumers in order to ensure the safety of the nation’s food supply. (Target: Increase the percentage of the U.S. population that will live in states that have adopted the Food Code.) New overall goal statement added; target the same

Center for Drug Evaluation and Research

12001

Ensure a safe and effective drug supply is available to the public.

Review and approve upon 90% of original standard NDAs within 10 months of receipt.

Review and approve upon 90% of original priority NDAs within 6 months of receipt.

Revised

Improve the efficiency and effectiveness of the new drug review program to ensure a safe and effective drug supply is available.

New FY 05 Target: Review and act upon 90% of original standard NDAs within 10 months of receipt.

Review and act upon 90% of original priority NDAs within 6 months of receipt.

New overall goal statement added and revised wording of target
12003 Ensure safe and effective generic drugs are available to the public. Revised Improve the efficiency and effectiveness of the generic drug review program to ensure safer and more effective generic drug products are available for Americans. New overall goal statement added
12007

Enhance postmarketing drug safety.

Coordinate with agency to develop methodology and resources to determine baseline for number of adverse drug experiences (ADEs) related to medication dispensing and administration errors in US hospitals.

Revised

Improve the Safe Use of Drugs in Patients and Consumers.

New FY 05 Target: 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.

New overall goal statement added and revised target to make it more quantifiable
12026

Increase the number of drugs that are adequately labeled for children.

Report on activities that are responsive to the Best Pharmaceuticals for Children Act and those that are triggered by the Pediatric Research Equity Act.

Revised

Increase the number of drugs that are adequately labeled for children and ensure the surveillance of adverse events in the pediatric population.

New FY 05 Target: Issue at least 8 written requests for drugs that need to be studied in the pediatric population and report to the pediatric advisory committee on adverse events for 7 drugs that receive pediatric exclusivity.

New overall goal statement added and revised target to make it more quantifiable
12045

Facilitate development and availability of medical countermeasures to limit the effects of the intentional use of biological, chemical, or radiologic/nuclear agents.

Support research activities and the application of appropriate regulatory mechanisms to facilitate development and availability of medical countermeasures

Revised

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.

New FY 05 Target: Coordinate and facilitate development for at least 5 medical countermeasures.

New overall goal statement added and revised target to make it more quantifiable
12048 Increase the number of drugs adequately labeled available for OTC use. Revised Improve the efficiency and effectiveness of the over-the-counter (OTC) drug review program to ensure a safe and effective drug supply is available. New overall goal statement added
12051 Create state-of-the-art information management systems and practices to move to a paperless environment (e-Government). Unchanged    
12052 Improve the capability and efficiency of pharmaceutical development and manufacturing. (formerly 12016) Unchanged    

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.
Unchanged
   
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 .  

Center for Veterinary Medicine

14020 Complete review and action on 90% of original NADAs & reactivations of such applications received in FY 05 within 270 days.

Revised

Promote safe and effective animal drug availability ensuring public and animal health by meeting ADUFA performance goals.

FY 05 Target: Complete review and action on 90% original NADAs and reactivation of such applications within 270 days.

The scope of this original premarket goal was broadened in order to reflect a comprehensive display of the Animal Drugs User Fee Act (ADUFA) goals.

The previous FY 05 CJ goal is now changed to a target under this new goal.

Center for Devices and Radiological Health

15007 Ensure at least 97% of an estimated 9,200 domestic mammography facilities meet inspection standards, with less than 3% with Level I (serious) problems. Revised 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 to correctly report the number of domestic mammography facilities.
15012 Expand implementation of the MedSun System to a network of 250 facilities. Revised Expand implementation of the MedSun System to a network of 350 facilities. Revised to reflect new facility target.
15027 Maintain inspection and product testing coverage of Radiological Health industry at 10% of an estimated 2000 electronic products. Unchanged    
15031 Complete Review and Decision on 80% of 180 day PMA supplements within 180 days./1 Unchanged    
15032 Complete Review and Decision on 75% of 510(k)s (Premarket Notifications) within 90 days./1 Unchanged    
15033 Complete Review and Decision on 70% of Expedited PMAs within 300 days./1 Revised Complete Review and Decision on 80% of Expedited PMAs within 300 days./1 Revised to reflect new expedited PMA target.

National Center for Toxicological Research

16003 Develop computer-based models and infrastructure to predict the health risk of biologically active products Revised Develop at least one protocol (proof of concept) to aid in defining drug toxicity studies and studies into mechanistic age-associated degenerative disease. Redefined to address research concepts that will evolve as a result of integrating NCTR systems toxicology functions into a unique systems biology research program that will effectively aid FDA in performing toxicity drug and chemical research studies.
16007 Develop risk assessment methods and build biological dose-response models in support of the Food Safety Initiative. Unchanged    
16012 Catalogue biomarkers and develop standards to establish risk in a bioterrorism environment Unchanged    
16014 Use new technologies (toxicoinformatics, imaging, proteomics, metabonomics, and microarray) to study the risk associated with how an FDA-regulated compound or product interacts with the human body. Unchanged    

Field Activities

Foods Field Activities

11040   New 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. This goal is a critical new measure and will eventually replace the Import Field Exams as the primary measure for import security.
11036 Perform 97,000 import field exams and conduct sample analyses on products with suspect histories. Revised   Changed to accurately reflect the performance that is attainable with current resources.
11020 Inspect 95% of estimated 7,200 high-risk domestic food establishments once every year. Revised Conduct postmarketing monitoring, food surveillance, inspection, and enforcement activities with the objective of reducing the health risks associated with food, cosmetics and dietary supplements products. (Target: Inspect 95% of estimated 6,800 high-risk domestic food establishments once every year.)

New overall goal statement added; target the same.

In addition, the current estimate of the FY 2005 high risk inventory has been reduced.

19013 Expand federal/state/local involvement in FDA’s eLEXNET system by having 104 laboratories participate in the system by the end of FY 05. Revised Expand federal/state/local involvement in FDA’s eLEXNET system by having 95 laboratories participate in the system. Changed to accurately reflect the performance that is attainable with current resources.
19015 Perform at least 1,000 Filer Evaluations under new procedures. Unchanged    
19016   Unchanged    
11041 New

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).

FY 05: Achieve and maintain accreditation for 6 laboratories

New goal added to highlight the importance of Field laboratory activities.
11020 Inspect 95% of estimated 7,200 high-risk domestic food establishments once every year. Revised Conduct postmarketing monitoring, food surveillance, inspection, and enforcement activities with the objective of reducing the health risks associated with food, cosmetics and dietary supplements products. (Target: Inspect 95% of estimated 6,800 high-risk domestic food establishments once every year.)

New overall goal statement added; target the same.

In addition, the current estimate of the FY 2005 high risk inventory has been reduced.

19013 Expand federal/state/local involvement in FDA’s eLEXNET system by having 104 laboratories participate in the system by the end of FY 05. Revised Expand federal/state/local involvement in FDA’s eLEXNET system by having 95 laboratories participate in the system. Changed to accurately reflect the performance that is attainable with current resources.
Human Drug Field Activities
12020 Inspect 55% of registered high-risk human drug manufacturers.

Revised

Increase risk-based compliance and enforcement activities to ensure product quality.

Target: Inspect 55% of registered high-risk human drug manufacturers.

New overall goal statement added

Biologics Field Activities

13012 Meet the biennial inspection statutory requirement by inspecting 50% of the approximately 2,700 registered blood banks, source plasma operations and biologics manufacturing establishments to reduce the risk of product contamination. Unchanged    

Animal Drugs and Feeds Field Activities

14006 Conduct targeted BSE inspections of 100% of all known renderers and feed mills processing products containing prohibited material. Revised (See 14009 below.)

This FY 05 CJ goal/target was changed to a target under the new postmarket goal.

(See 14009 below.)

14009 Maintain biennial inspection coverage by inspecting 50% of 1,440 registered animal drug and feed establishments. Revised

Ensure the safety of marketed animal drugs and animal feeds by conducting appropriate and effective surveillance and monitoring activities.

FY 05 Target(s): Maintain biennial inspection coverage by inspecting 50% of 1,390 registered animal drug and feed establishments; Conduct targeted BSE inspections of 100% of all known renderers and feed mills processing products containing prohibited material.

Two previous goals, the BSE goal and the biennial goal, are now targets under a new postmarket goal broadened in order to reflect a comprehensive display of the performance and cost of the CVM field surveillance and compliance work.

The previous FY 05 CJ biennial inspection goal is now a target under this new revised goal.

Also, FY 05 CJ goal/target 14006 became a target under this new revised goal.

Device and Radiological Health Field Activities

15005.01 Utilize Risk management to target inspection coverage for Class II and Class Ill domestic medical device manufacturers at 20% of estimated 5,550. Revised Utilize Risk management to target inspection coverage for Class II and Class Ill domestic medical device manufacturers at 20% of estimated 5,540. Revised to correctly report the number of firms
15005.02 Utilize Risk management to target inspection coverage for Class II and Class Ill foreign medical device manufacturers at 9% of estimated 2,500. Revised Utilize Risk management to target inspection coverage for Class II and Class Ill foreign medical device manufacturers at 7% of estimated 2,500. Changed to accurately reflect the performance that is attainable with current resources.
15025 Conduct 295 domestic and foreign BIMO inspections with an emphasis on scientific misconduct, data integrity, innovative products, and vulnerable populations. Unchanged    

Other Activities

19002 Implement 'shared services' concept and consolidate selected functions in the agency Dropped    
19003 Increase the number of Commercial Activities that will be reviewed for competitive sourcing. Unchanged    
19006 Increase percentage of contract dollars allocated to performance based contracts Unchanged    
19017 Implement Financial Enterprise Solutions, FDA’s version of UFMS Unchanged    
19008 Enhance the Agency Emergency preparedness and response capabilities to be better able to respond in the event of a terrorist attack. Unchanged    

 

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