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FDA's FY 2009 Congressional Justifications

Online Performance Appendix

January 30, 2008

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Introduction

The Online Performance Appendix is one of several documents that fulfill the Department of Health and Human Services' (HHS') performance planning and reporting requirements.  HHS achieves full compliance with the Government Performance and Results Act of 1993 and Office of Management and Budget Circulars A-11 and A-136 through HHS agencies' FY 2009 Congressional Justifications and Online Performance Appendices, the Agency Financial Report and the HHS Performance Highlights.  These documents can be found at: http://www.hhs.gov/budget/docbudget.htm and http://www.hhs.gov/afr/.  

The Performance Highlights briefly summarizes key past and planned performance and financial information.  The Agency Financial Report provides fiscal and high-level performance results.  The FY 2009 Department's Congressional Justifications fully integrate HHS' FY 2007 Annual Performance Report and FY 2009 Annual Performance Plan into its various volumes. The Congressional Justifications are complemented by the Online Performance Appendices, which consolidates all of the FDA performance information into a single location.

The FDA Congressional Justification and Online Performance Appendix can be found at ( http://www.fda.gov/oc/oms/ofm/budget/documentation.htm.)

Foods Outputs / Outcomes Table

Other Outcome Indicators Measured in the HHS Strategic Plan

1.  Complete review and action on the safety evaluation of direct and indirect food and color additive petitions, including petitions for food contact substances, within 360 days of receipt.  (213301)

Context:  The likely number of submissions to the food and color additives premarket review program has been uncertain for FY 2007 and FY 2008 because of statutory triggers in section 409(h) of the FD&C Act that might have dramatically increased the number of submissions to this program.  Our performance targets for FY 2008 and FY 2009 are based on our current level of certainty that program submissions will not dramatically increase during FY 2008 or FY 2009.

Performance:  In FY 2008 and FY 2009, FDA hopes to maintain performance close to or at the FY 2007 level. However, although this program has reached or exceeded its performance goal each of the last three years, program resources have continued to shrink.  One reason goals have continued to be met is that the actual number of submissions has fallen off over that time period.  Even a slight increase in the number or complexity of incoming submissions could dramatically reduce performance.  This goal is based in part on the assumption that the FCN program will be funded adequately in FY 2008 and FY 2009. 

2. Number of state, local, and tribal regulatory agencies in the U.S. and its Territories enrolled in the draft Voluntary National Retail Food Regulatory Program Standards and the percentage of the enrolled jurisdictions which meet 2 or more of the Standards.   (214101 and 214102)

Context:  Strong and effective regulatory programs at the state, local and tribal level are needed to prevent foodborne illness and reduce the occurrence of foodborne illness risk factors in retail and foodservice operations. The voluntary use of the Program Standards by a food inspection program reflects a commitment toward continuous improvement and the application of effective risk-based strategies for reducing foodborne illness.  The success that FDA's National Retail Food Team has had in increasing enrollment and use of the Standards reflects continued recognition that the Standards help programs improve food safety in foodservice and retail food establishments. Effective use of the Standards is assured by having enrolled complete program self-assessments to identify program strengths and areas for improvement.

Performance:    FDA exceeded its FY07 target by enrolling 43 additional state, local and tribal retail food inspection programs enrolled in the FDA Voluntary National Retail Food Regulatory Program Standards. This raised the total number of enrolled jurisdictions to 302.  97 of these 302, or 32%, of the enrolled jurisdictions reported meeting at least 2 of the 9 Program Standards, based on their own self assessments.   The FY 2008 and FY 2009 targets in the Outputs Table are based on an expectation of enrolling fifteen additional enrolled jurisdictions each year.  These targeted increases are more modest than previous year's enrollments in recognition that, in addition to enrolling new jurisdictions, ORA personnel must devote time and resources to assisting the growing number of enrollees with Program Standards implementation.  In fact, the target for FY08 and FY09 is to maintain the current percentage of those enrolled jurisdictions that meet 2 or more of the Standards at 32%.

3.  Increase consumer understanding of diet-disease relationships, and in particular, the relationships between dietary fats and the risk of coronary heart disease (CHD).   (212401, 212402, 212403)

Context:   Coronary Heart Disease (CHD) is the leading cause of death among Americans, accounting for more than 1 in 5 deaths annually. CHD is also the leading cause of premature, permanent disability in the labor force. Dietary factors, especially consumption of some fats, play a significant role in CHD risk.  One modifiable factor that is important for reducing mortality and morbidity associated with heart disease is consumer understanding of the consequences of dietary choices with respect to CHD. Increased understanding will strengthen motivation to adopt and maintain recommended healthy dietary behavior and to make informed dietary choices.  The target is directly in line with several of the Department's priorities and strategic goals. First, improving the American diet through informed choice about fats that increase or reduce the risk of heart disease is one of several important steps toward reducing the enormous morbidity and mortality burden of CHD. This burden is borne disproportionately by minority populations, including African-Americans, Hispanics, and Native Americans. As the leading cause of death and a significant cause of illness and disability, CHD also imposes substantial costs on the U.S. health care system.

Performance:  The baseline data for FY 2005 has been developed.   Although the target year for accomplishment was FY 2007, the protocol for implementing the Health and Diet Survey is under review.

4. Number of prior notice import security reviews.  (214201)

Context:   FDA's  Prior Notice Center (PNC)  was established in response to regulations promulgated in conjunction with the Public Health Security and Bioterrorism Preparedness Act of 2002 (BTA).  Its mission is to identify imported food and feed products that may be intentionally contaminated with biological, chemical, or radiological agents, or which may pose significant health risks to the American public, from entering into the U.S.  FDA will continue to focus much of its resources on Intensive Prior Notice Import Security Reviews of products that pose the highest potential bioterrorism risks to the U.S. consumer.  The FY 2008 and FY 2009 targets have been increased to 80,000 security reviews to better reflect recent historical actuals for this goal.  However, they are still lower than the FY 2007 actuals since it is unknown how many entries will be flagged for review as a potential security or public health risk in a given year.  All flagged entries (100%) are reviewed every year.  FDA expects that as prior notice compliance activities increase and targeting for high risk products becomes more sophisticated, the total number of intensive prior notice security reviews conducted by the PNC may decrease in future years.

Performance:  In FY 2007, FDA exceeded this goal of 60,000 by conducting 84,088 import security reviews.  The FDA Prior Notice Center collaborated with Customs and Border Protection to direct field personnel to hold and examine five (5) suspect shipments of imported foods; refused 390 lines of imported food for prior notice violations; conducted 333 informed compliance calls, responded to 29,490 phone and e-mail inquiries; and conducted the 84,088 intensive security reviews of the 9,804,001 Prior Notice submissions received in order to detect and intercept contaminated products before they enter the food supply.   Explanation of why this goal was significantly exceeded:  This goal is a difficult goal to set targets for because it is not known in advance how many food/feed entry lines will require an import security review, but FDA is required to review all of them.   Therefore, FDA must estimate a conservative target number each year to assure that there is still a reasonable opportunity to exceed the goal even if the number of lines requiring an import security review in a given year decreases from historical averages.  FDA has concluded that future targets should be adjusted upward based on actual performance data for the last several years.  The change in target should have minimal impact on FDA's ability to identify and prevent imported food and feed products that may be intentionally contaminated with biological, chemical or radiological agents, or which may pose a significant health risk to the American Public from entering the US.

5. Number of import food field exams on products with suspect histories.  (214202)

Context:   The volume of imported food shipments has been rising steadily in recent years and this trend is likely to continue.  FDA reviewed approximately 9.3 million line entries of imported food out of an estimated 15.9 million lines of FDA regulated products in FY 2007.  In FY 2009, FDA expects approximately 10.4 million line entries of imported food within a total of more than 18.2 million lines of FDA regulated entries.  To manage this ever-increasing volume of imports, FDA uses risk management strategies to achieve the greatest food protection with available resources.  While the percentage of imports physically examined may decline as imports continue their explosive growth, the exams that ORA conducts are more targeted and more effective than ever before.  ORA continues to think that the best approach to improve the safety and security of food import lines is to devote resources to expand targeting and follow through on potentially high-risk import entries rather than simply increasing the percentage of food import lines given a field exam.  The FY 2008 target is lower than the FY 2007 actuals because the FY 2007 actuals reflect unplanned Agency initiatives and emergencies that may not occur in the next year.  In FY 2009, FDA will use additional Food Protection resources to increase the number of import food field exams by 20,000 exams.

Performance:  In FY 2007, FDA exceeded this goal of 71,000 by completing 94,743 field examinations of imported food lines.   Explanation of why this goal was significantly exceeded:  It's difficult to estimate the target for this goal because there are several different risk factors that affect how many exams will be done in a certain year, including unplanned agency initiatives and emergencies.  Therefore, FDA must estimate a conservative target number each year to assure that there is still a reasonable opportunity to exceed the goal.   However, FDA has concluded that future targets should be adjusted upward based on actual performance data for the last several years. 

6. Number of Filer Evaluations of import filers.   (214203)

Context: The Food and Drug Administration (FDA) receives electronic import entry data for assessing the admissibility of regulated imported articles.  The accuracy of these data directly relates to the level of confidence that American consumers can expect in the quality, safety and compliance of imported articles subject to FDA's jurisdiction.   Entry data affects FDA's determination of the labeling, quality, safety, approval status, and efficacy of FDA-regulated import articles.  FDA uses an electronic entry screening system, Operational and Administrative System for Import Support (OASIS), to screen import entry data transmitted by import filers.  Filers who fail an evaluation must implement a Corrective Action Plan and pass a tightened evaluation.  This protects public health by ensuring reporting compliance for imported articles that FDA regulates.  FDA will continue to develop and apply methods to evaluate filer accuracy that are consistent with evolving security and import regulation practices.  The FY 2009 target is being maintained even though it is lower than the FY 2007 actuals because the historical accomplishments for this goal have decreased every year.

Performance: In FY 2007, FDA exceeded this goal of 1,000 by performing 1,355 filer evaluations.  This goal is an agency-wide goal and performance data includes activities from all five program areas; however, the majority of the performance activities and resources are from the Foods program. 

7. Number of examinations of FDA refused entries.  (214204)

Context:   FDA is responsible for the protection of the U.S. public regarding foods, drugs, devices, electronic products and cosmetics.  This protection includes refusing entry of products into the U.S. when they are deemed violative and assuring these violative products are either destroyed or exported and do not enter into domestic commerce.  Although primary responsibility for supervising destruction or exportation rests with the Bureau of Customs and Border Protection (CBP), FDA monitors the disposition of refused shipments and maintains an open file until the product is exported or destroyed.  In cooperation with CBP, FDA will, at times, supervise destruction or examine products prior to export in order to assure that the refused product is actually exported.  This performance goal only counts FDA supervised destruction or exportation of refused entries.  In other cases FDA relies on notification from CBP that the refused products have been destroyed or exported.  The FY 2008 and FY 2009 targets have been increased to 4,000 examinations to better reflect the recent historical actuals for this goal.

Performance:  In FY 2007, FDA exceeded this goal of 3,000 by performing 5,510 examinations of FDA refused entries as they were delivered for exportation to assure that the products refused by FDA were exported.  This goal is an agency wide goal and performance data will include activities from all five program areas; however, the majority of the performance activities and resources are from the Foods program. 

8. Number of high risk food inspections.    (214205)

Context: High risk food establishments are those that produce, prepare, pack or hold foods that are at high potential risk of microbiological or chemical contamination due to the nature of the foods or the processes used to produce them. This category also includes foods produced for at risk populations such as infants. The Field intends to inspect such establishments annually, or more frequently for those who have a history of violations. The FDA inventory of high-risk establishments is dynamic and subject to change.   For example, firms go out of business, new high-risk food firms enter the market, or the definition of high risk evolves based on new information on food hazards. High-risk establishment inspection frequencies vary depending on the products produced and the nature of the establishment. Inspection priorities may be based on a firm's compliance history.  The FY 2008 and FY 2009 targets have been increased over the FY 2007 target but are lower than the FY 2007 actuals because the available inventory of firms for this goal is highly variable.  Also, the FY 2007 actuals reflect unplanned Agency initiatives and emergencies that may not occur in subsequent years.

Performance:  In FY 2007, FDA exceeded this goal of 5,625 by performing 6,421 inspections of high-risk domestic food establishments.

9. Convert laboratories that participate in eLEXNET via manual data entry to automated data exchange.  (214301) 

Context: The electronic Laboratory Exchange Network (eLEXNET) is a seamless, integrated, secure network that allows multiple agencies (federal, State and local health laboratories on a voluntary basis) engaged in food safety activities to compare, communicate, and coordinate findings of laboratory analyses.  eLEXNET enables health officials to assess risks, analyze trends and provides the necessary infrastructure for an early-warning system that identifies potentially hazardous foods. To date, 135 laboratories representing multiple government agencies and all 50 states are contributing data into the eLEXNET system allowing the program to successfully populate its database with valuable information for use in threat detection, risk assessment, inspection planning, and traceback analysis.  eLEXNET plays a crucial role in the Nation's food testing laboratory system and is an integral component of the Nation's overall public health laboratory information system.  FDA anticipates that increasing data exchange participation will enhance the utility of the data, improve data quality, and increase the effectiveness of the nation's food security efforts.

Performance:  FDA exceeded the previous FY 2007 goal by creating informational reports on 8 specific analytes and 5 select agents.  eLEXNET automatically sends recurring reports regarding 8 analytes including salmonella in peanut butter, colors in all products, pesticide residue in all products, elemental analysis in all products, antibiotic residues in all products, E. coli in spinach, Shigella in all products, and results of FDA's protein surveillance assignments.  eLEXNET also routinely sends reports to FERN laboratories on 5 select agents including Bacillus anthracis, clostridium botulinum, clostridium perfringens, aflatoxin, and ricin.  The FY 2008 target reflects the new goal to convert manual data entry to automated for which accomplishment data will not be available until the end of FY 2008.

10. Establish and maintain accreditation for ORA labs.  (214206)

Context:  FDA is a science-based agency that depends on its regulatory laboratories for timely, accurate, and defensible analytical results in meeting its consumer protection mandate.  Our laboratories have enjoyed a long history of excellence in science upon which the agency has built its reputation as a leading regulatory authority in the world health community.  Accreditation of laboratory quality management systems provides a mechanism for harmonizing and strengthening processes and procedures, thereby improving the quality of operations and the reliability of FDA's science.  Such accreditations allow FDA to maintain its reputation as a source of scientifically sound information and guidance both domestically and in the international arena.

Performance:  In FY 2007, FDA met this laboratory accreditation goal. FDA maintained accreditation for 13 laboratories: Denver District Lab, Forensic Chemistry Center, Arkansas Regional Lab, Pacific Regional Lab Northwest, San Francisco District Lab, Winchester Engineering and Analytical Center, New York Regional Lab, Southeast Regional Lab, San Juan District Lab, Detroit District Lab, Pacific Regional Lab Southwest, and Kansas City District Lab. Philadelphia District Lab underwent a renewal assessment in November 2007.

All ORA Field Laboratories are accredited to ISO 17025 by the American Association for Laboratory Accreditation.  FCC is accredited by the ASCLD (American Society of Crime Laboratory Directors).

11. Increase laboratory surge capacity in the event of terrorist attack on the food supply.   (Radiological and chemical samples/week)   (214305)    

Context: A critical component of controlling threats from deliberate food-borne contamination is the ability to rapidly test large numbers of samples of potentially contaminated foods for the presence of contaminants.  To address the need for this surge capacity, The Food Emergency Response Network (FERN), a joint effort between USDA/FSIS and HHS/FDA, was created.  FERN is a nationwide laboratory network that integrates existing federal and State food testing laboratory resources capable of analyzing foods for agents of concern in order to prevent, prepare for, and respond to national emergencies involving unsafe food products.  Improvements in surge capacity will have public health value even in non-deliberate food contamination by assisting FDA in identifying and removing contaminated food products from the marketplace as soon as possible in order to protect the public health and mitigate disruption in the U.S. food supply chain.  FDA awards FERN Cooperative Agreements for chemistry and radiological FERN labs to the States.  After receiving the funding, State FERN laboratories can take up to one year to reach full capacity due to the need for training and testing to ensure confidence in the laboratory results.  As a result, labs funded in one fiscal year will not show surge capacity until the following year.

Performance:  In FY 2007, FDA met this performance goal when the 2 State Radiological Laboratories funded in FY 2006 were provided equipment and training to support their analytical surge capacity of 1,000 radiological samples per week.  FDA also maintained the surge capacity for 1,200 chemical samples (known analyte) per week.  Also in FY 2007, FDA awarded Cooperative Agreements to 3 State Radiological Laboratories to increase the capacity to respond to radiological attacks on the food supply. These 3 laboratories are the basis for the increase of 1,500 radiological samples per week in the FY 2008 surge capacity goal.

Human Drugs Outputs / Outcomes Table

1.   Percentage of Standard NDAs/BLAs and Priority NDAs/BLAs within 10 months.    (223201 and 223202)

Context:  This performance goal focuses primarily on improving the effectiveness and efficiency with which the FDA processes new drug and biologics licensing applications.  Central to that focus is FDA's commitment to meeting PDUFA goals and requirements.  The Food and Drug Administration Amendments Act of 2007 reauthorized collection of user fees to enhance the review process of new human drugs and biological products and established fees for applications, establishments, and approved products.  A key determinant in knowing if CDER is effective and efficient is to measure the time to "first action."  The first action is the first regulatory action CDER takes (complete response, approvable, not approvable, or approval letter) at the end of the review of the original NDA/BLA submission (the first review cycle).  The"first action time" refers to the time it takes to review and take an action on the original submission.  This statistic is different from "total approval time" which is the time it takes from the original receipt of the application until it is approved, which may take more than one review cycle.  "Total approval time" includes time spent reviewing an application in each of the review cycles plus the time taken by the sponsor to respond to the issues raised in the complete response or approvable/not approvable letter(s) and to re-submit the application for review.  CDER's featured targets under this performance goal are to measure time to first action for "priority" submissions and "standard" submissions.  Applications for drugs similar to those already marketed are designated standard, while priority applications represent drugs offering significant advances over existing treatments.  In FY 2009, FDA continues to maintain the target set for this goal in the PDUFA legislation. 

Performance:  CDER will not have the final performance numbers for the FY 2007 submission cohort until November 2008.  The latest information on CDER's performance toward the targets for this performance goal is from FY 2006.  In FY 2006, CDER met or exceeded all of the PDUFA review performance goals, including exceeding the goals for reviewing priority and standard NMEs and new BLAs. 

2.   Number of Written Requests (WRs) issued for drugs that need to be studied in the pediatric population and number of drugs reported to the pediatric advisory committee on adverse events for drugs that receive pediatric exclusivity. (223101)

Context:  The context of the Pediatric Program's performance goal in CDER covers the activities and requirements of the various laws passed to ensure safe and effective drug products are available for children, including the Best Pharmaceuticals for Children Act (BPCA), which provides incentives to manufacturers who conduct studies in children including a 6-month extension of marketing exclusivity for conducting pediatric studies requested by FDA, and the Pediatric Research Equity Act (PREA) which provides FDA the authority to require pediatrics studies for certain new and already marketed drug and biological products.

Performance:  The target for FY 2007 performance was to issue at least 7 written requests to drug sponsors 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.  CDER issued 30 Written Requests to sponsors: 28 for on-patent drugs and 2 for drugs on NIH's annual Priority List, as required by the Best Pharmaceuticals for Children Act.  CDER reported to 2 Pediatric Advisory Committee meetings on adverse events for 13 drugs that received pediatric exclusivity.

3.   The total number of actions taken on abbreviated new drug applications in a fiscal year. (223205)

Context:  The Office of Generic Drugs (OGD) has experienced a dramatic increase in workload, with the number of generic drug applications almost doubling over the past 4 years at a time when staffing levels have increased less than 20%.  Consequently, the previous measure (the percentage of new applications for which first action is taken within 180 days) no longer reflects FDA's current program management challenge to increase throughput and productivity to address the higher workload while maintaining standards of quality and safety.  Therefore, FDA has determined that a more meaningful performance goal for the generic drug program is the number of total actions taken on abbreviated new drug applications. The total number of actions includes approvals, tentative approvals, not approvable, and approvable actions on applications. 

Performance:   In FY 2008, we hope to remain near the FY 2007 performance level with a target of 1780 actions.  During this time, OGD will move to the FDA White Oak campus, which is expected to cause a disruption in productivity.  Also, OGD operated under a Continuing Resolution during the first quarter of FY 2008, which has also caused a delay in hiring and training new staff for the program.  In FY 2009, the target is 1900 actions, an increase of almost 7%.  This reflects both the estimated increase in performance as new staff that are expected to be hired in FY 2008 are trained and achieve full performance levels, as well as the estimated increase in performance due to increased staffing levels proposed for FY 2009.  At the time this budget was developed, FDA and industry are in discussions about the terms of a generic drug user fee program that could begin in FY 2009.

4.   Percentage of Rx-to-OTC Switch applications within 10 months receipt in which there was a complete review action. (223206)

Context:  OTC drug monographs are "recipes" for marketing OTC drug products without the need for FDA pre-clearance. The monographs list the allowed active ingredients and the dosage or concentration, the required labeling, and packaging and testing requirements if applicable. The monographs save manufacturers costs and reduce barriers to competition, as they allow both large and small companies to enter the market place with OTC drug products that have to meet the same, uniform criteria.  Final monographs (agency final rules) need to be completed for a number of large product categories (e.g., external analgesics, internal analgesics, antimicrobials, oral health care products, laxatives).   In the next 5 years, FDA plans to complete the initial review of OTC monographs for 29 categories of drug products, thereby eliminating all unsafe and ineffective products from the OTC market.  The ability to reach these goals will depend on maintaining experienced staff in all facets of rulemaking development and improvement in the efficiency of the FDA document clearance process.

Performance: FDA exceeded its 2007 target by completing review and action on 100% of Rx-to-OTC switch and direct to OTC applications within 10 months of receipt and making significant progress on 9 OTC monographs: (1) Internal Analgesic, Antipyretic, and Antirheumatic Drug Products - Organ Specific Warnings (proposed rule published 12/06); (2) OTC Vaginal Contraceptive Products Containing N9 - Required Labeling; (3) Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products - Nasal; Decongestants, Phenylephrine (subject of Advisory Committee discussion 12/07); (4) Insect Repellant-Sunscreen Drug Products (request for data published 2/07); (5) Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products (final rule published 3/07); (6) Sunscreen Drug Products (proposed rule published 8/07); (7) Topical Antimicrobial Drug Products - Healthcare and Consumer Antiseptics; (8) Labeling for OTC Drug Product - Convenience Size Labeling Rule (proposed rule published 12/06); and (9) Laxative Drug Products, Granular Psyllium Warning (final rule published 3/07).

5.   Reduction in FDA approval time for the fastest 50 percent of standard New Molecular Entities/Biologics Licensing Applications approved for CDER and CBER, using the 3-year submission cohort for FY 2005-2007.  (223207)

Context: Reducing unnecessary delays in the approval time for safe and effective drugs that truly represent new therapies [i.e., new molecular entities (NMEs) and biologics] means earlier patient access for these medicines. Reducing unnecessary delays in drug approval also helps to both control the cost of new drug development, cited as a factor affecting the cost to consumers, and supports market competition among innovators. This is both good for the drug industry and good for consumers. New drug development presents uncertainties that increase the business risk and costs to the innovator. Higher costs can create barriers to competition both from new drugs with therapeutic value - but not blockbuster potential, and new innovators that don't have access to the capital available to more established pharmaceutical companies. Although some scientific and technical uncertainties are inherent and unavoidable in drug innovation, others can be reduced or eliminated, helping speed patient access to new drugs, and reducing the cost of drug development.  FDA has begun major initiatives to reduce those sources of uncertainty.  The targeted reductions in this FDA outcome goal represent approximately 10.5 percent reductions in total FDA review times for priority and standard NMEs and BLAs. Using Tufts estimates of potential cost reductions by phase of drug development, a 10 percent reduction in regulatory review time yields a 1.6 percent reduction in total capital costs, now estimated at $802 million, translating to a savings of $12.8 million per NME approved.

Performance: The FDA approval time for the fastest 50 percent of standard NME and biologics licensing applications (BLAs) approved in CDER and CBER for the FY 2001-2003 cohort is 523 days as compared to 575 days for the baseline FY 1999-2001 submission cohort. This is a reduction of 52 days versus the FY 2005-2007 target of a reduction of 61 days.  An update of progress on this goal for the FY 2004 submission cohort is not expected until January 2008.

6.   Reduction in FDA time to approval or tentative approval for the fastest 70 percent of original generic drug applications approved or tentatively approved of those submitted using the 3-year submission cohort for FY 2005-2007. (223208)

Context:  FDA achievement of this goal will create earlier access to lower cost drug alternatives for patients. The high cost of drugs limits patient access to treatment. The lower income and uninsured populations are particularly affected.  Research has shown that 42 percent of the uninsured do not fill prescriptions because of financial reasons. The Center for Medicaid and Medicare Services has stated that the new Medicaid prescription drug coverage has come in under budget and points to the availability of more generic products as a factor in this outcome.  Increasing the availability of generic drugs will make many important treatments more affordable to the poor and the elderly and significantly improve access to treatment.  Optimal access and use of generic drugs will enable policy decision makers to contain costs in both the Medicare and Medicaid programs. This will only become more important as more of the top selling brand name drugs go off patent over the next few years.

Performance:  The FDA approval time for the fastest 70 percent of original generic drug applications approved for the FY 2003-2005 cohort is 17.8 months as compared to 17.9 months for the baseline FY 1998-2000 submission cohort.  This is an increase from the FY 2002-2004 cohort of 16.0 months. Despite the exponential increase in receipts, new resources to manage the increased workload have increased only marginally. 

7.   Number of medical countermeasures in which there has been coordination and facilitation in development. (223102)

Context:  In the Federal Government's response to a biological, chemical, or radiological/nuclear attack or to a natural disaster, drugs will be mobilized from the CDC's Strategic National Stockpile (SNS). However, not all drugs in the SNS are FDA-approved as countermeasures against threat agents or emerging infections.  FDA has been taking an aggressive and proactive approach to identify and facilitate development of new therapeutic options as well as to obtain information on existing approved drugs that may be used for an unapproved indication.  For example, although gentamicin has not been FDA-approved for treatment of plague, it is widely recommended as a preferred therapy by experts.  Human clinical trial data and animal efficacy data have been generated to determine the safety and efficacy of gentamicin for specific plague treatments.  Identification of gaps in the therapeutic armamentarium and development of a plan to address these gaps will move the FDA closer to a goal of labeling all drugs that reside in the SNS for counterterrorism uses.  FDA is also active in department and agency efforts to prepare for other emergencies, such as natural disasters and pandemics.

Performance:  CDER facilitated the development of and access to medical countermeasures for counterterrorism and emerging infections through these actions:

• Cyanokit (hydroxocobalamin) was approved as an antidote to cyanide poisoning. The kit contains the drug hydroxocobalamin, intravenous tubing, and a sterile spike for reconstituting the drug product with saline.  Approval of this product improves the nation's ability to respond to emergencies, including potential terrorist attacks.
• A supplement for Tamiflu (oseltamivir phosphate) was approved to provide instructions for pharmacists for the preparation of a suspension using the contents of Tamiflu capsules in an emergency setting, when the commercially manufactured oral suspension is not available.  CDER also approved Tamiflu 30 mg and 45 mg capsules for the treatment of influenza.  Previously, Tamiflu was available in 75 mg capsules and in an oral suspension for pediatric patients.  These supplements for the lower dosage strengths also provide for carton and container labeling for the marketed product, Department of Defense stockpiles, state stockpiles, and the Strategic National Stockpile. 
• Updated Home Preparation Instructions for doxycycline have been finalized and will be available for use by emergency response planners and public health personnel.  In a terrorism event, if pediatric dosage forms are not available, tablets or capsules can be crushed with food. 
• Enrollment for the third and final year of the CDER/CDC collaboration on human trials of gentamicin in plague in Africa has been completed.  Efforts continue with NIH/NIAID and USAMRIID on monkey studies of gentamicin, ciprofloxacin, levofloxacin, ceftriaxone, and doxycycline in pneumonic plague. 

8.   Improve the Safe Use of Drugs in Patients and Consumers. (222301)

Context:  CDER is working toward a policy of more transparency to ensure that patients and physicians have the most up-to-date and complete information necessary to make their treatment decisions.  The Food and Drug Amendments Act (FDAAA), sweeping new legislation signed by the President in September 2007, for the first time recognizes FDA's critical role in assuring the safe and appropriate use of drugs after they are marketed.  FDAAA gives FDA substantial new resources for medical product safety, as well as a variety of regulatory tools and authorities to ensure the safe and appropriate use of drugs.   Congress, along with the recommendations made over the past two years by the Institute of Medicine, the Government Accountability Office (GAO), and a multitude of others, directed FDA to shift its regulatory paradigm to recognize that ensuring that marketed products are used as safely and effectively as possible is equally as important as getting new safe and effective drugs to market quickly and efficiently.   With increased focus and resources on post-marketing, CDER is moving toward establishing procedures and tools for tracking, managing, and monitoring safety issues in much the same way that pre-market issues are tracked according to PDUFA requirements.  Activities in FY 2006 and FY 2007 to standardize communications policies and procedures and to develop a tracking system to capture information about known and emerging safety issues established a foundation upon which CDER can now begin to build the capacity and capability to more effectively manage safety issues in a timely fashion.

Performance:  In FY 2007, CDER met its target of establishing a tracking system for postmarketing safety issues. The safety application functions to track postmarketing safety issues as well as archive reviews, forms, and correspondence pertaining to the tracked issues. The system also has a report generating function so that managers can monitor active issues.  CDER will be focusing its efforts in FY 2008 on increasing its staff resources for tracking, managing, and monitoring safety issues.  The Center will be conducting a pilot for prioritizing safety issues, developing action plans and timelines for those issues, and monitoring and managing progress toward those plans.  During the first year of this new process, CDER is targeting acting upon at least 50 percent of the identified priority safety issues within an established timeframe.

9.   Reduce the Unit Cost associated with turning a submitted Adverse Event Report into a verified record in the database. (222201)

Context:  The collection and analysis of data by FDA staff must occur throughout the entire life cycle of the product to identify unexpected safety risks associated with the use of a human drug that could not have been predicted by clinical trials and biostatistical analysis. Reports of these unexpected safety problems, called adverse events, are captured in the Adverse Event Reporting System (AERS), a critical component of FDA's post-marketing safety surveillance systems for all drug and therapeutic biologic products.  Information captured in AERS allows FDA scientists and statisticians to search for patterns that may indicate an emerging safety hazard, which is the first step in analyzing the potential causes and formulating an effective risk management response.  FDA is working to make AERS more efficient by improving the data entry work processes and reengineering the system to increase the percentage of electronic submissions, to reduce the amount of manual re-keying, along with other efficiencies.  These system improvements will allow the FDA to reduce the average cost and time associated with turning a submitted Adverse Event Report into a verified record in the database.  This improvement in efficiency will allow scientists and statisticians to access safety information sooner, and will free up resources that can be redirected to risk analysis activities that directly improve our ability to recognize and respond to drug safety problems.

Performance:  The average cost associated with turning a submitted Adverse Event Report into a verified record in the database has been decreasing since FY 2003 due to FDA efforts to streamline its business processes and improve the information systems that are used to process records.  In FY 2003, the cost per report was $21.91/per report.  In FY 2004, the cost per report was $19.30/per report.  In FY 2005, the cost per report was $17.35/per report.  In FY 2006, the cost per report was $16.47/per report.  FDA expects to achieve further improvements in efficiencies due to improved automation of the submission and validation processes, and outreach to improve adoption of electronic submissions.  The proposed FY 2007 target of $15 per report represents almost a 32% reduction in cost per adverse event report compared to the FY 2003 level, not including inflationary impacts.

10.    Reduce medication errors in hospitals through increased adoption of bar code medication administration technology. (222202)

Context:  In November 1999, the Institute of Medicine released a report estimating that as many as 98,000 patients die from medical errors in hospitals alone.  Many of these deaths, as well as additional non-fatal illnesses, are associated with errors involving FDA regulated medical products, especially medications.  A significant percentage of drug related mortality and morbidity results from errors that are preventable.  In addition to their human cost, these errors impose significant economic costs on the U.S. health care system.  The total cost of preventable adverse events has been estimated at $17 Billion.  Preventing some of the adverse drug events related to medication errors in U.S. hospitals will significantly reduce related morbidity, mortality and health care costs. 

The Secretary of Health and Human Services directed FDA to promulgate the bar coding regulation to reduce preventable errors from medical products.  This rule is expected to enable the uptake and use of bar code scanners that will allow a health professional to compare the bar code on a human drug product to a specific patient's drug regimen and then verify that the right patient is receiving the right drug, at the right dose, via the right route, at the right time.  Research to date has demonstrated the ability of bar code scanners at the point of care to intercept errors in dispensing and administration of medications and thereby prevent related adverse events.  Consequently, this measure tracks the adoption rate of bar code medication administration technology in hospitals, with the expectation that increased adoption rates will be directly related to decreased medication error-related adverse events. 

Performance:  The results of the American Society of Health-System Pharmacists (ASHP) 2006 annual survey of pharmacy practice in hospital settings (dispensing and administration) were published in 2007.  Over the last few years the adoption rate of bar code medication administration technology has grown each year, up to 13.2% overall in 2006, with a slightly higher rate of adoption in larger hospitals. The differentiation between small and large hospitals is becoming less each year.

11.    Number of foreign and domestic high-risk human drug inspections. (224201)

Context: FDA is continuing to develop a more quantitative risk model to help predict where FDA's inspections are most likely to achieve the greatest public health impact.  The Risk-Based Site Selection Model provides a risk score for each facility, which is a function of four component risk factors - Product, Process, Facility, and Knowledge. In the FY 2007 model, the Agency developed several enhancements and improvements and will continue to explore ways to enhance calculations of process risk and facility sub-scores in FY 2009.  As enhancements are made to FDA's data collection efforts and to the Risk-Based Site Selection Model, FDA will improve its ability to focus inspections on the highest-risk public health concerns in a cost-effective way.

Performance: FDA exceeded the FY 2007 goal of 500 by inspecting 583 high-risk foreign and domestic drug manufacturers.

Biologics Outputs / Outcomes Table

1.   Complete review and action on standard original PDUFA NDA and BLA submissions within 10 months of receipt.  (233201)

Context:  The Prescription Drug User Fee Act (PDUFA) authorizes the FDA to collect fees from the prescription drug and biologic drug industries to expedite the review of human drugs and biologics so they can reach the market more quickly. Standard original BLAs are license applications for biological products, not intended as therapies for serious or life-threatening diseases. In FY 2009, FDA continues to maintain the target set for this goal in the PDUFA legislation. 

Performance: FDA tracks PDUFA performance by year-of-receipt, which FDA calls the cohort year, and complete performance data is not available until the prescribed review time, i.e., 10 months after receipt, is expired, making the FY 2007 data unavailable until November of 2008.  In FY 2006, CBER exceeded its goal by completing review and action on 100 percent of 2 standard applications within 10 months of receipt and has met or exceeded this performance goal since 1994.

2. Complete review and act on priority original PDUFA NDA/BLA submissions within 6 months of receipt. (233202)

Context:  The Prescription Drug User Fee Act authorizes the FDA to collect fees from the prescription drug and biologic drug industries to expedite the review of human drugs and biologics so they can reach the market more quickly.  A BLA will receive priority review if the product, would be a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease.  In FY 2009, FDA continues to maintain the target set for this goal in the PDUFA legislation. 

Performance: FDA tracks PDUFA performance by year-of-receipt, which FDA calls the cohort year and complete performance data is not available until the prescribed review time, i.e., 6 months after receipt, is expired, making the FY 2007 data unavailable until April of 2008.  In FY 2006, CBER exceeded its goal by completing review and action on 100 percent of 3 priority applications within 6 months of receipt and has met or exceeded this performance goal since 1994.

3. Complete review and action on standard PDUFA efficacy supplements within 10 months of receipt.  (233203)

Context: The PDUFA authorizes the FDA to collect fees from the prescription drug and biologic industries to expedite the review of human drugs and biologics so they can reach the market more quickly.  An efficacy supplement is a change to an approved licensed product to modify the"approved effectiveness" of a product such as a new indication, and normally requires clinical data.  In FY 2009, FDA continues to maintain the target set for this goal in the PDUFA legislation. 

Performance: FDA tracks PDUFA performance by year-of-receipt, which FDA calls the cohort year and complete performance data is not available until the prescribed review time, i.e., 10 months after receipt, is expired, making the FY 2007 data unavailable until November of 2008.   In FY 2006, CBER exceeded its goal by completing review and action on 100% of 9 standard PDUFA efficacy supplements within 10 months of receipt has met or exceeded most of these performance goals since 1994.   

4. Complete review and action on complete blood bank and source plasma BLA submissions within 12 months after submission date. (233205)

Context:  In FY 2009 CBER will work to complete review and action on 90 percent of the complete blood bank and source plasma BLA submissions within 12 months.  Since so few complete blood bank and source plasma submissions are received by FDA, the actual performance may be significantly different than the target.  User fee resources are not available for blood bank and source plasma BLA supplements. 

Performance:  CBER tracks performance by year-of-receipt, which FDA calls the cohort year and complete performance data is not available until the prescribed review time, i.e., 12 months after receipt, is expired, making the FY 2007 data unavailable until November of 2008.  In FY 2006, CBER exceeded its goal by reviewing and acting on 100% of 2 submissions within 12 months of receipt.

5. Complete review and action on complete blood bank and source plasma BLA supplements within 12 months after submission date. (233206)

Context:  In FY 2009 CBER will work to complete review and action on 90 percent of the complete blood bank and source plasma BLA submissions within 12 months.  FDA does not expect to exceed the target, as we have in past years, since user fees are not available for blood bank and source plasma BLA supplements. 

Performance:  CBER tracks performance by year-of-receipt, which FDA calls the cohort year and complete performance data is not available until the prescribed review time, i.e., 12 months after receipt, is expired, making the FY 2007 data unavailable until November of 2008.  In FY 2006, CBER exceeded its goal by reviewing and acting on 100% of 326 supplements within 12 months of receipt.

6. Increase manufacturing diversity and capacity for pandemic influenza vaccine production.  (234101)

Context: The Biologics Program has received appropriated funding to establish the infrastructure and surge capability to react to a potential disease pandemic.  Influenza pandemics are explosive global events in which most, if not all, persons worldwide are at risk for infection and illness.  Pandemic Influenza strains, such as avian influenza, can rapidly change and current vaccines will not provide protection.   Industry will need to produce vaccines for pandemic influenza on a short notice and FDA needs to provide new and accelerated pathways to facilitate their rapid production and evaluation.   This goal changes on a yearly basis to ensure continued progress in preparation for a pandemic outbreak.   In FY 2007 the targets include:  Issue one guidance or concept paper to facilitate development of non-egg-based influenza vaccines; evaluate the potency of monovalent influenza vaccines from at least three manufacturers by using quality systems guidelines; demonstrate two new or improved methods for improved influenza vaccine manufacture; develop at least four influenza virus vaccine strains optimized for growth in non-egg culture systems by using quality systems guidelines.   In FY 2008 the pandemic target is to: facilitate rapid development, evaluation and availability of at least one new pandemic influenza vaccine, and one new trivalent vaccine; demonstrate one improved method for evaluating the safety, potency or immunogenicity of influenza vaccines; and establish international regulatory cooperation, harmonization and information sharing in vaccine evaluation and safety activities by participating in one international workshop or conference. The 2009 pandemic target is to begin to develop a pilot program that utilizes a national healthcare database to evaluate the safety of potential pandemic vaccines and participate in at least one international workshop or conference. 

Performance:  In FY 2006, CBER accomplished all of it targets for this goal.  The targets included:  developing 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 on non-egg based influenza vaccines and co-sponsor two workshops with WHO an pandemic vaccines.   In FY 2007, CBER met all of its pandemic targets.  This included: issuing the guidance "Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines" to facilitate development of non-egg-based influenza vaccines; evaluated the potency of five influenza vaccines (four inactivated and one live)  using quality systems guidelines; demonstrated four methods for improved influenza manufacture and develop four influenza virus vaccine strains optimized for growth in non-egg culture systems by using reverse genetics and recombination on the backbone of A/Puerto Rico/8/34 virus. 

7.   Number of high risk registered domestic blood bank and biologics manufacturing inspections.  (234202)

Context: FDA will increase risk-based compliance and enforcement activities by inspecting the highest priority registered manufacturers of biological products.  The highest priority firms will be those whose operations are determined to be the highest risk, new product types in need of an inspectional history to evaluate and stratify risk, and, emergency response situations.  Inspections for the goal are conducted to ensure compliance with Current Good Manufacturing Practices (CGMPs), and to ensure, as appropriate, the safety, purity and potency of biological products.  There are currently an estimated 2,450 establishments in the Biologics program inventory covered under the cGMP regulation. The biologics inventory includes high-risk establishments such as blood collection facilities, plasma fractionator establishments, and vaccine manufacturing establishments, especially seasonal and pandemic influenza vaccines.

Performance:  In FY 2007, FDA exceeded the previous statutory inspection goal of 1,138 by inspecting 1,256 blood banks, source plasma and biologics manufacturing establishments.  The FY 2008 target reflects the new high-risk prioritized goal for which accomplishment data will not be available until the end of FY 2008.

8.   Number of highest priority human tissue establishment inspections.   (234203)

Context: Beginning in FY 2006 as a result of new regulations, the human tissue inspection goal was created.  FDA's responsibility for enforcing the new regulations and the need to quickly assess compliance makes tissues one of the highest priorities.  Two new rules took effect regarding human tissue: one requiring tissue facilities to register with FDA became effective January 2004; while the "Donor Eligibility Rule" became effective May 2005.  The Field conducts tissue inspections to determine if human tissues for transplantation are in compliance with FDA tissue regulations and to assure consumer protection from unsuitable tissue products and disease transmission which may endanger public health.  In FY 2009, FDA will increase this goal by 45 additional tissue inspections in order to cover more of the firms that registered as a result of the new regulations.  However, the FY 2008 and 2009 targets are lower than the FY 2007 actuals because the FY 2007 actuals reflect a one-time Agency blitz of US companies to look for problems related to tissue recovery issues uncovered in FY 2006.

Performance:  In FY 2007, FDA exceeded the human tissue goal of 325 by conducting 427 inspections under new regulations.

Animal Drugs and Feeds Program Outputs / Outcomes Table