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Detail of Performance Analysis

<< Return to FY 2006 Budget Summary

 

CFSAN's Performance Goals

Performance Goals Targets Actual Performance Appendix Reference
  1. Provide premarket reviews within statutory time frames to assure the safety of food ingredients, bioengineered foods and dietary supplements. (11001)

Complete review and action on the safety evaluation of 75% of food and color additive petitions within 360 days of receipt.

FY 06: 75%
FY 05: 75%
FY 04: 75%
FY 03: 65%
FY 02: 60%
FY 01: 50%
FY 00: 40%
FY 99: 30%

 

 

FY 06:
FY 05:
FY 04: 10/05
FY 03: 80% of 5
FY 02: 75% of 8
FY 01: 70% of 10
FY 00: 91% of 99
FY 99: 77% of 50

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  1. Respond to 95% of notifications for dietary supplements containing "new dietary ingredients" within 75 days. (11025)
FY 06: NA
FY 05: NA
FY 04: 95%
FY 03: 95%
FY 02: 95%
FY 01: 90%
FY 00: 90%
FY 99: NA
FY 06:
FY 05:
FY 04: 95% of 49
FY 03: 100% of 58
FY 02: 99% of 44
FY 01: 100% of 22
FY 00: 100% of 25
FY 99: 100% of 23
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  1. Review 95% of premarket notifications for food contact substances within the statutory time limit (120 days). (11034)
FY 06: NA
FY 05: NA
FY 04: 95%
FY 03: 95%
FY 02: 95%
FY 01: NA
FY 00: NA
FY 06:
FY 05:
FY 04: 100% of 103
FY 03: 100% of 111
FY 02: 100% of 70
FY 01: 100% of 82
FY 00: 99% of 83
4
  1. Increase risk management strategies and communication to government, industry and consumers in order to ensure the safety of the nation's food supply. (11010)

Increase the percentage of the U.S. population that will live in states that have adopted the Food Code.

FY 06: 49 States/ 84%
FY 05: 49 States/ 84%
FY 04: 43 states / 83%
FY 03: 42 states
FY 02: 28 states
FY 01: 25 states
FY 00: 18 states
FY 99: 13 states

 

FY 06:
FY 05:
FY 04: 44 states/75%
FY 03: 43
FY 02: 40
FY 01: 28
FY 00: 20
FY 99: 15

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Outcome Goal

Supports Healthy People 2010 Objectives

1. 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.) (11001).

  • Context of Goal: In this goal, performance is defined in terms of a review of all parts of a petition. This review would be followed by issuance of a "not approvable" letter, or by publication of a response in the Federal Register, if appropriate.

    This goal refers to completion of the safety evaluation of food and color additive petitions. This includes a review of the information in a filed petition, and one of two conclusions reached: either the petition does not support the requested action and a letter to that effect is transmitted to the petitioner with an explanation of why we reached the conclusion; or based on the review, we are prepared to recommend to the agency officials authorized to sign an order, that the use of the additive be approved (or denied), and communication of this information to the petitioner. It does not include the time to get the order and accompanying rationale for our decision reviewed, signed, and published in the Federal Register.

    Almost uniquely among products FDA regulates, food and color additives are not permitted to be marketed by means of correspondence from the agency to the petitioner (except in the case of food additives that are food contact substances, see below). Rather, the statute provides that the agency must, using formal rulemaking, publish in the Federal Register an order laying out the conditions by which anyone (not just the petitioner) may use a food or color additive, or an order denying the request to use a food or color additive, with an explanation in each case of how we came to our conclusions. (Alternatively, a petitioner may choose to withdraw a petition. In that case, the Agency publishes a notice of the withdrawal in the Federal Register). The law also provides a variety of administrative remedies to those who object to FDA's order to permit, or deny, use of a food or color additive, these include stays and administrative hearings. (For example, in the case of a color additive order, any objection automatically stays the regulation). Although objections are not routine, when they occur, they necessitate further "action" on the part of the agency. However, we, and our stakeholders, have considered publication of an order in the Federal Register as "final action".

    We have used the time to complete the evaluation of a petition as the goal because it is relatively unambiguous and measurable. It is also the part of the entire process that is most within the control of the organizations responsible for administering the food and color additive petition review process and thus most amenable to improvement by those organizations. Publishing an order in the Federal Register is subject to factors outside the agency's control. (For example, the statute requires public notice of filing of food and color additive petitions; comments to such filing, which must be reviewed and possibly responded to, may be submitted at any time prior to publication.) Completion of the safety evaluation is also the step that is most analogous to final action in the case of the dietary supplement and food contact substance premarket review processes. Because stakeholders are most interested in publication of a final order, we recognize the need to make all involved parties accountable for reducing the total time to publication as much as possible.

    The 360-day time frame used in this goal is not the same as the statutory time frame (i.e., 90 days, extendable to 180 days). It is widely recognized that meeting the current statutory time frame is an unrealistic goal for all food and color additive petitions, especially the more complex ones. The impracticability of the current time frame was acknowledged in a report from a June 1995 House hearing and FDA recommended a change from the statutory time frame to '360 days of receipt' in a testimony before the House Committee on Government Reform and Oversight in 1996.

    Subsequently, the Food and Drug Administration Modernization Act (FDAMA) established a notification process for food contact substances. The premarket notification program began to operate fully on January 18, 2000. With the full implementation of the premarket notification program, many of the simpler food additive petitions that were completed within 360 days were filed under the notification program, thus decreasing the workload for this goal. However, since the remaining petitions are likely to be more complex and take more time to review, the Agency anticipated that performance on this goal could decline initially. Once the notification and the recent improvements to the petition review process are well established, FDA expects performance on this goal to increase substantially toward full performance in succeeding years.

  • Performance: In FY 2000, FDA exceeded its goal of completing the review of 40%, respectively, of food and color additive petitions with 360 days. The high performance figures in 1999 and 2000 do not presage similar numbers in later years. This is primarily because Congress passed, under the FDA Modernization Act of 1997, and implemented in FY 2000, the Food Contact Substance Premarket Notification Program. As a result, we are now receiving far fewer petitions than in previous years. Those that we do receive are for direct food additive uses of greater potential public health significance, which generally take more time and effort per petition to complete. In addition, as the new PMN program was being implemented, many pending petitions for food contact materials were withdrawn, leading to "completed actions" on many petitions. This artifact led to the increased performance figures for the receipt cohorts of FY 1999 and FY 2000. This, however, was a one-time phenomenon. For the petition receipt cohort of FY 2001, the Food's program completed the safety evaluation in less than 360 days for 7 out of 10 (70%) food and color additive petitions that do not qualify for expedited review. This meets our goal to complete 60% of these petitions within 360 days. For the petition receipt cohort of FY 2002, completed within 360 days of filing, the safety evaluation of six of the eight (75%) food and color additive petitions that do not qualify for expedited review. This meets our goal of completing at least 70% of these petitions within 360 days. We have conducted a careful analysis of these trends. Based on all available data, including receipt of far fewer (but generally far more labor intensive) petitions than in previous years, we project that completing review of 65% of food and color additive petitions in 360 days for the 2003 receipt cohort is a fair and challenging level of performance. For the petition receipt cohort of FY 2003, completed within 360 days of filing, the safety evaluation of four (80%) of five food additive petitions that do not qualify for expedited review. This exceeds our goal of completing at least 65% of these petitions within 360 days. Information for FY 2004 will be available in October 2005.
  • Data Sources: CFSAN's electronic workflow system

2. Respond to 95% of notifications for dietary supplements containing "new dietary ingredients" within 75 days. (11025)

  • Context of Goal: FDA reviews premarket notifications for new dietary ingredients (NDI) of dietary supplements. Once the notification is received it is reviewed for completeness and justification of safety. A letter is issued to the submitter acknowledging receipt of the notification and raising safety concerns if identified. This represents final action. This letter and notification are filed in Dockets Management Branch 90 days after receipt of the notification. This is the end of the process. The number of notifications the Agency received in FY 2002 more than tripled compared to what it received in FY 2001 (i.e., receipt of approximately 50 notifications for FY 2002 as of August 2002 versus receipt of 16 notifications in FY 2001). The complexity of the notifications also has increased in recent years. Nevertheless, the Agency will retain its review goal target of 95% for FY 2003 through FY 2005. Since the Agency does not know precisely what the workload will be in any given year, the 95% target is considered full performance.

    Additionally, in response to the additional regulatory responsibilities placed on FDA by the Dietary Supplement Health and Education Act of 1994 (DSHEA), FDA has also developed a Strategic Plan for implementing those responsibilities both in the premarket and postmarket areas. FDA's goal is to have a science-based regulatory program that will provide the Agency with the ability to successfully implement and carry out the regulatory responsibilities imposed by DSHEA within ten years, thereby providing consumers with a high level of confidence in the safety, composition, and labeling of dietary supplement products. The success of this strategy will, however, not only depend on adequate funding levels, but also on FDA's new and continued partnerships with other government agencies, academia, health professionals, industry, and consumers.

  • Performance: FDA completed 100% of its reviews of NDI notifications within the 75-day deadline from FY 1998 -FY 2001. Due to the overlapping nature of a 75-day period, a notification review may be completed during the same or following fiscal year in which it was received. In addition, a notification may be received prior to the fiscal year in which the review was completed. Based upon this scenario, the following data represents the actual number of NDI notification reviews completed within the stated fiscal year: 20 in FY 1998;23 in FY 1999; 25 in FY 2000; and 22 in FY 2001. In FY 2002, the Agency reviewed 44 notifications for new dietary ingredients. All except one were reviewed within the 75-day statutory timeframe. Of the 44 notifications reviewed, 10 were filed without comment; 3 were filed with comments; and 31 were filed with objection (3 of the 31 were not dietary supplements and the remaining 28 notifications had one or more of the following deficiencies: did not meet minimum requirements of 21 CFR 190.6; did not provide an adequate basis that the new dietary ingredient was reasonably expected to be safe; or made disease claims for the new dietary ingredient, thereby representing if as a drug).

    During FY 2003, CFSAN filed and responded to all 58 notifications for dietary supplements containing new dietary ingredients within the 75 day period. The notifications are reviewed for science-based evidence of safety. Letters were issued to the notifier to acknowledge receipt and, when necessary, to identify deficiencies and safety. During FY 2004, CFSAN filed 49 and responded to 47 notifications for dietary supplements containing new dietary ingredients. The notifications are reviewed for science-based evidence of safety. Letters are issued to the notifier to acknowledge receipt and, when necessary, to identify deficiencies and safety concerns. A total of 31 letters identified deficiencies or safety concerns, one (1) did not fulfill the regulations found at 21 CFR 190.6, eight (8) were acknowledgements and seven (7) were not dietary ingredients.

  • Data Sources: CFSAN's Correspondence Tracking System and manual tracking

3. Review 95% of premarket notifications for food contact substances within the statutory time limit (120 days). (11034)

  • Context of Goal:As provided in the Food and Drug Administration Modernization Act (FDAMA), the Agency was mandated to establish a premarket notification program for food contact substances as a vehicle to re-inventing the premarket review process for food and color additives. The Congress appropriated resources in FY 2000 to fully fund this Program, and the first notifications became effective in March 2000. The statute provides that a food contact substance notification shall become effective (i.e., the food contact substance may be lawfully marketed) 120 days after receipt unless the Agency objects that the use of the food contact substance has not been shown to be safe. Thus, to ensure that unsafe food contact substances do not enter the marketplace, the program goal is to review all notifications within 120 days. "Final action" is used in the case of food contact substances because nothing more needs to be done before the substance can be legally marketed, unless we object, which is also a final action.
  • Performance: In FY 2000, the Agency completed review of 82 of 83 notifications for food contact substances within 120 days. In FY 2001, the Agency received 80 notifications and completed review of 82 notifications, all within 120 days of receipt. The number reviewed includes those that became effective or were withdrawn or placed in abeyance because of deficiency during the previous fiscal year. In FY 2002, the Agency completed review of all (70) premarket notifications for food contact substances within 120 days. In FY 2003, CFSAN completed review of all 111 Food Contact Notifications within the 120-day statutory timeframe. In FY 2004, CFSAN completed the review of all 103 Food Contact Notifications within 120-day statutory timeframe.
  • Data Sources:CFSAN's electronic workflow system; Internal Office of Pre-Market Approval database.

4. 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.) (11010)

  • Context of Goal: The Food Code is a reference document for regulatory agencies responsible for overseeing food safety in retail outlets, such as restaurants and grocery stores, and institutions, such as nursing homes and child care centers. It is neither federal law nor federal regulation, but may be adopted voluntarily and used by agencies at all levels of government that have responsibility for managing food safety risks.

    To achieve the public health goal of reducing foodborne illness to the fullest extent possible, steps must be taken at each point in the farm-to-table chain where hazards can occur. Adoption by all jurisdictions of the Food Code would result in uniform national standards and provide the foundation for a more uniform, efficient, and effective, national food safety system. FDA endorses the Food Code because the Code provides public health and regulatory agencies with practical science-based advice and manageable, enforceable, provisions for mitigating risk factors known to contribute to foodborne disease.

    The Food Code is a component of an even larger effort aimed at decreasing foodborne illness, the National Retail Food Regulatory Program Standards program. In FY 2004, FDA will assist state programs and provide oversight in implementing the Standards program, and complete the data compilation of the national baseline data collected by CDC during FY 2003. Additionally, FDA plans to enroll 60 new jurisdictions in the Standards and baseline program in each year FY 2004 through FY 2009, while continuing to provide support and guidance to those 120 jurisdictions already enrolled. FDA will conduct audits of those enrolled in the Standards program in accordance with the Standards protocol.

  • Performance: The Food Code has been revised and published every two years since 1993 with the latest in 2001. Also in 2001, the Association of Food and Drug Officials began a survey for FDA of State, Territorial, Local and Tribal Nations to track adoption of regulations or codes patterned after the FDA Food Code. That survey continues to track these adoptions and to develop a current data base to determine which jurisdictions have patterned their retail food regulations after the Food Code and which of the versions of the Food Code are being used. Currently, 44 of 56 State and Territories have adopted codes patterned after the 1993, 1995, 1997, 1999 or 2001 Codes. They represent 79% of the U.S. population (2000 Census).At the start of the survey, (2001), 72% of the population was in States using one of the FDA Food Codes. Currently, many States are upgrading their older codes to pattern after the 1999 or 2001 versions of the FDA Food Code. Of the remaining 12 States and Territories,10 are actively pursuing Food Code adoption rule-making.(Arkansas, California, Guam,Kentucky, Maryland, New Jersey, New York, North Carolina, Vermont, Virgin Islands, and Washington)Rule-making by States can often take two or more years. Now 22 States pattern their codes after the 1999 FDA Food Code and 10 have adopted the 2001 Food Code. As the Agency achieves greater success towards getting all States and Territories to adopt the Food Code, it is believed that a more accurate picture of success from a direct public health standpoint is to quantify actual performance for this goal in terms of the percentage of the total US population that will live in States that have adopted the Food Code rather than the number of States that have adopted the Food Code. This new measurement will also take into account the demographic differences (population) that exist from State to State and region to region to avoid any impression that all states are equal. This change will be effective starting in FY 2004.

    The FY 2004 goals were to have 43 out of 56 states and territories with a food code modeled after our food code, and to have 83% of the U.S. population covered.

    At the close of FY04, 44 of 56 states and territories (above our goal) had adopted food code provisions modeled after the FDA food code. However, this covered only 75% of the U.S. population (less than our goal), because California, which had indicated in its previous survey responses that its food code was modeled after the FDA Food Code, responded in 2004 that it does not model its food code after FDA's. (The wording in the most recent survey was modified from previous survey wording to help states more clearly determine whether their current food codes are modeled after FDA's food code.) California represents about 12% of the U.S. population. It does anticipate that its retail food code will be based on the FDA Food Code with adoption projected for 2006, and implementation by January 1, 2007.

    As of December 2004, 48 out of 56 states and territories, covering 79% of the U.S. population, responded that they have food codes modeled after FDA's food code.

  • Data Sources: Field Data Systems

 

CDER's Performance Goals

Performance Goals Targets Actual Performance Reference

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

(12001)

(Formerly: Ensure a safe and effective drug supply is available to the public.)

Meet PDUFA III commitments for the review of original NDA submissions by including:

Standard NDA's within 10 months:

FY 06: 90%
FY 05: 90%
FY 04: 90%
FY 03: 90%
FY 02: 90%
FY 01: 70%
FY 00: 50%
FY 99: 30%

Priority NDA's within 6 months:

FY 06: 90%
FY 05: 90%
FY 04: 90%
FY 03: 90%
FY 02: 90%
FY 01: 90%
FY 00: 90%
FY 99: 90%

 

 

 

FY 06:
FY 05:
FY 04: 10/05
FY 03: 100% of 82
FY 02: 99% of 84
FY 01: 90% of 86
FY 00: 79% of 92
FY 99: 66% of 95
FY 06:
FY 05:
FY 04: 10/05
FY 03: 100% of 19
FY 02: 100% of 12
FY 01: 100% of 10
FY 00: 97% of 29
FY 99: 100% of 31

4

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

(12026)

FY 06: Issue at least 10 written requests (WR's) 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.

FY 05: 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.

FY 04:

  1. Issue WR's for the study of on-patent drugs in the pediatric population
  2. Make exclusivity determinations once final study reports are submitted,
  3. Determine final pediatric labeling information & disseminate the information
  4. Post on web all medical/clinical pharmacology reviews at the time of action and publish FR notices.
  5. Work with NIH to publish annual Priority List of Drugs
  6. Issue 4-6 WR's for off-patent drugs;
  7. Work with NIH to issue RFP's for contracts for the study of drugs outlined in a WR (this is dependant on NIH's funding).
  8. Track all applications that trigger the study requirement under the Pediatric Research Equity Act, to include, waivers, deferrals and completed studies.

FY 06:

FY 05:

FY 04:

  1. Issued 15 on-patent drug Written Requests to sponsors and issued 40 amendments to sponsors of existing Written Requests. Referred 5 on-patent Written Requests declined by sponsors to the Foundation for the NIH
  2. Final study reports submitted: 17; Exclusivity determinations: 20; Exclusivity granted: 19
  3. Label changes: 23 labeling changes made and posted on the web.

    Info disseminated: 3 Pediatric Advisory Subcommittee meetings; 1 Pediatric Advisory Committee meeting; 1-yr post-pediatric exclusivity adverse event reporting: 24 drugs presented; 1 FDA/NIH Newborn Workshop; 2 AAP Committee on Drugs Meetings; 33 outside presentations/liaison activities; 5 abstracts; 5 articles/chapters; 4 posters; 6 AAP News

  4. Medical/clinical pharmacology reviews posted: reviews for 22 drugs posted at the time of action and reviews for 5 additional SSRI's were made public
  5. Annual Priority List Published: Published in the FR on 2/13/04
  6. Off-patent Written Request issued: 4
  7. NIH RFP/contracts: FDA has been collaborating with NIH to issue 5 RFP's/contracts for off-patent Written Requests.
  8. Tracking all applications that trigger the study requirement under the PREA, including waivers, deferrals and completed studies in an internal Access database. A dedicated CDER-wide PREA tracking system is under development.
4

3. Improve the efficiency and effectiveness of the generic drug review program to ensure safer and more effective generic drug products are available for Americans. (12003)

(Formerly: Ensure safe and effective generic drugs are available to the public.)

FY 06: Decrease the average FDA time to approval or tentative approval for the fastest 70% of original generic drugs applications by 0.5 months.

Complete review and action upon fileable original generic drug applications within 6 months after submission date.

FY 05: 90%
FY 04: 85%
FY 03: 80%
FY 02: 65%
FY 01: 50%
FY 00: 45%FY 99: 60%

 

 

 

FY 06:
FY 05:
FY 04: 4/05
FY 03:90% of 449
FY 02: 85% of 339
FY 01: 84% of 298
FY 00: 56% of 307
FY 99: 28% of 309

4

4. Improve the efficiency and effectiveness of the over-the-counter (OTC) drug review program to ensure a safe and effective drug supply is available. (12048)

(Formerly: Increase the number of drugs adequately labeled available for OTC use)

FY 06: 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.

FY 05: 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.

FY 04: 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.

FY 03: NA

FY 06:

FY 05:

FY 04: Reviewed and acted on 100% of Rx-to-OTC Switch Applications within 10 months of receipt. Made significant progress on completing 8 OTC monographs: vaginal contraceptive drug products containing Nonoxynol 9; antacids; internal analgesic, antipyretic, and antirheumatic; laxatives; cold, cough, allergy, bronchodilator, and antiasthmatic; miscellaneous external drug products such as dandruff control, seborrheic dermatitis, and psoriasis; diaper rash; and sunscreen

FY 03: NA

4
5. Create state-of-the-art information management systems and practices to move to a paperless environment (e-Government).(12051)

FY 06: NA

FY 05: 35% of ANDA's contain some electronic portion.

FY 04:

  • Receive NDA's electronically using eCTD format;
  • 85% original NDA's with some electronic portion;
  • 50% original NDA's completely electronic;
  • 20% supplemental applications completely electronic;
  • 20% supplemental applications with some electronic portion;
  • 30% ANDA's with some electronic portion

FY 03:

  • 80% original NDA's with some electronic portion;
  • 55% original NDA's completely electronic;
  • 15% supplemental applications completely electronic;
  • 5% supplemental applications with some electronic portion

FY 06:

FY 05:

FY 04:

  • CDER began receiving NDA's electronically using eCTD format;
  • 77.6% original NDA's with some electronic portion;
  • 0% original NDAS completely electronic;
  • 5.9% supplemental applications completely electronic;
  • 27.8% supplemental applications with some electronic portion;
  • 72.5% new ANDA's with some electronic portion

FDA missed some of the targets because FDA does not require electronic submissions and cannot control the number received.

FY 03:- 66.7% original NDA with some electronic portion;

  • 9.2% original NDA completely electronic;
  • 5.2% of supplemental applications totally
  • 24.2% supplemental applications with some electronic portion; electronic.

FDA missed this target because the Agency does not require electronic submissions and cannot control the number received.

8, 4

Efficiency Goal

6. 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. (12045)

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

FY 06: Coordinate and facilitate development for at least 6 medical countermeasures.

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

FY 04:

  1. Develop list of high priority products for countermeasures and a plan to periodically review and update list;
  2. Develop guidance(s) for industry and stakeholders related to evaluating products under development or for which there is a need to develop products for medical countermeasures;
  3. Facilitate drug development of countermeasures for plague;
  4. Review existing data for ribavirin for viral hemorrhagic fevers;
  5. Facilitate intra-Agency program for development of radiological countermeasures

FY 03:

  • Develop guidance for Industry on developing antiviral drugs;
  • Identify and begin to address labeling gaps in the therapeutic armamentarium;
  • Expedite the review of protocols for investigational new radioprotectant drugs; - Facilitate human clinical trials.

FY 06:

FY 05:

FY 04:

  1. CDER developed lists of products under development for uses against radiological/nuclear, chemical, and Category A biological agents. CDER also prioritized products as potential Emergency Use Authorization candidates.

    Four new drug and 16 generic drug applications were approved with counter-terrorism indications.

  2. Guidance's: Published 1 final and 1 draft guidance. One draft guidance in clearance process. Comments to previously published draft guidance are being addressed. Two new Guidance's in draft. CDER has also contributed to drafting an Agency guidance on the emergency use authorization of medical products.
  3. Plague Countermeasures: Studies of 5 antibiotics in non-human primate pneumonic plague model continued. Enrollment began in the clinical trials of gentamicin for human plague in Africa.
  4. Ribavirin review completed.
  5. Intra-Agency Animal Rule Working Group (ongoing). Nuclear/ Radiological Therapeutic Countermeasures Working Group (ongoing)

FY 03:

  • Guidance: Vaccinia complications guidance cleared by DHHS and press release prepared;
  • Anthrax Guidance undergoing revisions.
  • Radioprotectant drugs: Approval of Radiogardase;
  • FR finding of safety and efficacy for Ca- and Zn-DTPA; Guidance's issued for Prussian Blue, DTPAs, and KI shelf-life extension

    Human clinical trials: Plague studies in Africa

2, 4

 7. Improve the Safe Use of Drugs in Patients and Consumers (12007)

(Formerly: Enhance postmarketing drug safety.)

FY 06: Review and provide comments on 100% of Risk Minimization Action Plans (RiskMAPs) for NME's and for those products for which the sponsor or FDA initiated discussions, in accordance with applicable PDUFA goal dates.

FY 05: Review and provide comments on 100% of Risk Minimization Action Plans (RiskMAPs) for NME's and for those products for which the sponsor or FDA initiated discussions, in accordance with applicable PDUFA goal dates.

FY 04:

  • Increase receipt of periodic ADE reports and Periodic Safety Update Reports (PSUR's) electronically (submission electronically is voluntary);
  • Publish final Industry guidance on good risk assessment and risk management, and pharmaco-vigilance practices (PDUFA-3);
  • Enhance AERS to support medication error capture and analysis;
  • Encourage industry to submit majority of ADE reports (all types) electronically;
  • Finalize rulemaking for electronically submitting drug registration and listing information

FY 03:

  • Publish draft guidance to Industry on good risk assessment, risk management, and pharmacovigilance practices. Major reporting companies will be submitting all types of ADR reports electronically. Goal: 40% of all expedited ADR reports.

FY 06:

FY 05:

FY 04: The receipt of PSUR's increased from 9,710 reports in FY 2003 to 24,189 in FY 2004, a 149% increase.

  • Concept papers on good risk assessment, risk management, and pharmaco-vigilance practices have been published, discussed, and commented on by the public. All three drafts published in May 2004, however, publication of the final guidance is taking longer than expected due to clearance delays
  • CDER made significant progress in determining what requirements are needed to enhance the AERS system and in preparing for a competitive procurement to obtain contractor support to make changes to AERS.
  • Two meetings (October and April) focusing on electronic reporting were held with approximately 25 participating manufacturers to further promote and advance the conversion from paper to electronic submission of AE reports. There was a 90% increase in electronic submission of ADE reports from FY 2003 (35,759) to FY 2004 (69,111).
  • FDA has not finalized the rule requiring electronic submission of drug registration and listing information. This rule making involves hundreds of pages of very complex information. Effort to develop and clear the draft rule has taken longer than anticipated. FDA expects to publish a proposed rule in FY 2005.

FY 03:

  • Developed draft guidance documents for good risk assessment, risk management, and pharmacovigilance - Received 357,392 ADE reports (total) including 139,148 expedited (serious, unexpected) reports.
  • 26,049 (19%) Expedited reports submitted electronically. (The current percentage is less than the goal of 40% because firms are not currently required by regulation to submit reports electronically.)
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8. Give consumers and health professionals more easily understandable, accessible, timely, and accurate prescription and OTC drug information. (12027)

FY 06: NA

FY 05: NA

FY 04:

  • Initiate 3 new public education campaigns and continue work on 2 in progress.
  • Prove the technical concepts for an Electronic Labeling Information Processing System (ELIPS), Medication Information Databases for new drug applications (MedID), and FDA/NLM public Ingredient Dictionary

FY 03: NA

FY 06: NA

FY 05: NA

FY 04:

  • CDER initiated 3 new public educations and completed 2 public campaigns on Acetaminophen/Liver Warning and NSAIDS GI Bleeding Warning.
  • After conducting a variety of proof of concept activities, CDER successfully documented a business case for developing ELIP's, MedID, and an Ingredient Dictionary.

FY 03: NA

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9. Improve the capability and efficiency of pharmaceutical development and manufacturing.

(12052 - Formerly 12016)

FY 06: NA

FY 05: cGMP: Continue progress in implementing an integrated quality management system; implement a risk-based site selection model for inspections based on results of pilot

FY 04:

  1. cGMP: Develop a Quality Systems framework for ensuring Pharmaceutical quality;
  2. Publish draft guidance for cGMP quality system principles for comment;
  3. Begin designation of specialized staff to form a Pharmaceutical Inspectorate (PI);
  4. Pilot a risk-based site selection model for inspections

FY 03: PAT - Present during 1 trade meeting and 2 conferences.

Meet with 2 potential applicants.

Prepare a draft guidance.

PQRI - Move toward 25% of completion for each of the three projects. (Initiate draft blend uniformity guidance in response to PQRI comments and participate in 2 PQRI work groups to develop recommendations)

FY 06:

FY 05:

FY 04:

  1. cGMP: The quality system framework document was officially adopted by the FDA Management Council on March 18, 2004;
  2. FDA developed draft guidance for three separate cGMP issues - all of which support quality system principles;
  3. FDA determined the staff who would form the PI and began training those staff;
  4. CDER developed the risk-based model for site selection in FY 2004 and plans to pilot it in FY 2005.

FY 03: PAT - Presented during 1 trading meeting and discussed initiative during two conferences. Met with 2 potential applicants. Draft guidance was issued in August 2003.

PQRI - Submitted comments regarding the blend uniformity document prepared by PQRI and participated in two PQRI Work Groups

4, 8

 1. Improve the efficiency and effectiveness of the new drug review program to ensure a safe and effective drug supply is available. (12001) (Formerly: Ensure a safe and effective drug supply is available to the public.)

  • Context of Goal: This performance goal focuses primarily on improving the effectiveness and efficiency with which the FDA processes new drug applications. Central to that focus is FDA's commitment to meeting the goals and requirements of the Prescription Drug User Fee Act (PDUFA). The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 reauthorized the 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. FDA's timely performance of high-quality drug reviews in recent years reflects the importance of managerial reforms and substantial additional resources provided under the Prescription Drug User Fee Act (PDUFA).

    Consistent with the PDUFA requirements, a major objective of the human drugs program is to reduce the time required for review of all drugs. A key determinant in knowing if CDER is making progress in reducing time is to measure the time to "first action". The first action is the first regulatory action CDER takes (approvable, not approvable, or approval letter) at the end of the review of the original NDA 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 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. (For example, drugs for Acquired Immune Deficiency Syndrome (AIDS) and cancer typically fall into the priority category.)

  • Performance: CDER will not have the final performance numbers for FY 2004 until October 2005. The latest information on CDER's performance toward the targets for this performance goal is from FY 2003. In FY 2003, CDER exceeded all PDUFA goals, including first actions on NDA's

Performance toward the standard and priority NDA submissions, and other PDUFA goals, is provided in the following table:

Fiscal Year 2003 First Action Review Performance
(Cohort closed as of October 31, 2004)
  Number Filed

2003 Performance Goal

Final Performance

NDA's

Standard

19

90% in 10 mo.

100%

Priority

82

90% in 6 mo.

100%

NME's

Standard

19

90% in 10 mo.

100%

Priority

10

90% in 6 mo.

100%

NDA Resubmissions

Class 1

24

90% in 2 mo.

96%

Class 2

38

90% in 6 mo.

100%

Efficacy Supplements

Standard

103

90% in 10 mo.

97%

Priority

35

90% in 6 mo.

100%

Efficacy Resubmissions

Class 1

16

30% in 2 mo.

94%

Class 1

16

90% in 6 mo.

100%

Class 2

40

90% in 6 mo.

100%

Manufacturing Supplements

Requiring Prior Approval

617

90% in 4 mo.

97%

CBE

1079

90% in 6 mo.

99%

First Cycle Filing Review Notification

NDA

104

50% within 14 days after 60 day filing

84%

Efficacy Supplements

105

50% within 14 days after 60 day filing

85%

The graph below illustrates that total approval time in months for priority applications has decreased from 15 months in 1994 to 6 months in 2001, increased to 19.1 months in 2002, and decreased to 7.7 months in 2003. FY 2002 saw a steep rise in median total approval times for priority NDA's and NME's This increase was a statistical artifact caused by the approval of a number of older applications remaining from the 1999 and 2000 receipt cohort coupled with a significant decrease in the number of priority applications received in 2001 and 2002. With a smaller pool of recent priority applications with short approval times, the remaining "tail" of submissions for earlier years dominated the median approval time statistic. Total approval time for standard applications has decreased from 22.1 months in 1994 to 14 months in 2001 and increased slightly to 15.3 and 15.4 months in 2002 and 2003 respectively. Total approval time represents the total review time at the Agency plus Industry response time to the Agency's requests for additional information.
  • Data Sources and Issues: Review performance monitoring is being done in terms of cohorts, e.g., FY 2003 cohort includes applications received from October 1, 2002, through September 30, 2003. CDER uses the Center-wide Oracle Management Information System (COMIS) and New Drug Evaluation/Management Information System (NDE/MIS). FDA has a quality control process in place to ensure the reliability of the performance data in COMIS.

2. Increase the number of drugs that are adequately labeled for children and ensure the surveillance of adverse events in the pediatric population. (12026)

  • Context of Goal: The context of the Pediatric Program's performance goal covers the activities and requirements of the various laws passed to ensure safe and effective drug products are available for children. Due to the inadequacy of pediatric use information found in the majority of prescription medications in the United States, Congress passed several legislative initiatives to promote drug development for children. In 1997, the Food and Drug Administration Modernization Act (FDAMA) was signed into law with section 111 providing incentives to manufacturers who conduct studies in children. This incentive program, which provides six months of additional marketing exclusivity in return for conducting pediatric studies requested by the FDA, was reauthorized in January 2002 under the Best Pharmaceuticals for Children Act (BPCA). As a result of these initiatives, the number of ongoing pediatric clinical trials in the last 5 years has increased dramatically. Many of the studies reported to date have yielded new dosing and safety information in labeling. On December 3, 2003, the Pediatric Research Equity Act (PREA) was enacted. This law provides FDA the authority to require pediatrics studies for certain new and already marketed drug and biological products. PREA incorporates many elements of the former "Pediatric Rule" (63 FR 66632, Dec. 2, 1998) that was struck down in U.S. District Court for the District of Columbia on October 17, 2002. The effective date of PREA is retroactive to April 1, 1999, the same date the former Pediatric Rule became effective. Due to the retroactive nature of the legislation, a significant number of previously submitted applications are now subject to the requirements.

    Since 1998, FDA has reviewed 363 Proposed Pediatric Study Requests (PPSR), issued 298 Written Requests (WR) for on-patent drugs asking for over 687 studies to be conducted in the pediatric population, and has granted exclusivity to 106 out of the 116 products that have had an exclusivity determination. Eight-seven of the 116 products that have had an exclusivity determination now have approved labeling that incorporates information from the pediatric studies. Accurate dosing and safety information is now available for products labeled for use in asthma, allergies, diabetes mellitus, high blood pressure, pain, seizures, obsessive-compulsive disorder, HIV infection, atopic dermatitis, and many other conditions.

  • Performance: In previous performance plan submissions, CDER has included a variety of aspects of the Pediatrics program in its target for the Pediatric Program performance goal. The following table displays the details for the targets each year previously submitted. The text following the table provides actual measurements of performance for the FY 2004 and FY 2003 targets.

 

    FY 2005 FY 2004 FY 2003

BPCA: on-Patent Drugs

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.
  1. Issue WR's for the study of on-patent drugs in the pediatric population
  2. Make exclusivity determinations once final study reports are submitted,
  3. Determine final pediatric labeling information & disseminate the information
  4. Post on web all medical/clinical pharmacology reviews at the time of action and publish FR notices.
  1. Complete review and action on 80% of pediatric supplements in response to a WR within 6 months.
  2. Work with NIH to publish the initial Priority List of Drugs and work with NIH to update the list.
  3. Issue WR's for the study of on-patent drugs in the pediatric population
  4. Make exclusivity determinations once final study reports are submitted, E. Determine final pediatric label changes, and disseminate information.

BPCA: off-Patent Drugs

Target See above
  1. Work with NIH to publish annual Priority List of Drugs
  2. Issue 4-6 WR's for off-patent drugs;
  3. Work with NIH to issue RFP's for contracts for the study of drugs outlined in a WR (this is dependant on NIH's funding).
  1. Issue 6-8 WR's for off-patent drugs
  2. Work with NIH to issue RFP's for contracts for the study of drugs (outlined in a WR)
  3. Publish 5-7 RFP's

PREA

Target See above
  1. Track all applications that trigger the study requirement under the Pediatric Research Equity Act, to include, waivers, deferrals and completed studies.
  1. Track all applications that would have triggered the pediatric rule, to include waivers, deferrals, and completed studies.

FY 2004 performance is summarized in the following list:

  1. Issue WR's for the study of on-patent drugs in the pediatric population:
    • Issued 15 on-patent drug Written Requests to sponsors and issued 40 amendments to sponsors of existing Written Requests.
    • Referred 5 on-patent Written Requests declined by sponsors to the Foundation for the NIH
  2. Make exclusivity determinations once final study reports are submitted:
    • Final study reports submitted: 17
    • Exclusivity determinations: 20
    • Exclusivity granted: 19
  3. Determine final pediatric labeling information & disseminate the information:
    • Label changes: 23 labeling changes made and posted on the web
    • Info disseminated: 3 Pediatric Advisory Subcommittee meetings; 1 Pediatric Advisory Committee meeting; 1-yr post-pediatric exclusivity adverse event reporting: 24 drugs presented; 1 FDA/NIH Newborn Workshop; 2 AAP Committee on Drugs Meetings; 33 outside presentations/liaison activities; 5 abstracts; 5 articles/chapters; 4 posters; 6 AAP News
  4. Post on web all medical/clinical pharmacology reviews at the time of action and publish FR notices:
    • Medical/clinical pharmacology reviews posted: reviews for 22 drugs posted at the time of action and reviews for 5 additional SSRI's, that did not fall under the provisions of Section 9 of the BPCA, were made public.
  5. Work with NIH to publish annual Priority List of Drugs:
    • Annual Priority List Published in the FR on 2/13/04
  6. Issue 4-6 Written Requests for off-patent drugs:
    • Off-patent Written Requests issued: 4
  7. Work with NIH to issue RFP's for contracts for the study of drugs outlined in a WR (this is dependent on NIH's funding):
    • NIH RFP/contracts: FDA has been collaborating with NIH to issue 5 RFP's/contracts for off-patent Written Requests.
  8.  Track all applications that trigger the study requirement under the Pediatric Research Equity Act, to include, waivers, deferrals and completed studies:
    • Tracking all applications that trigger the study requirement under the Pediatric Research Equity Act, including waivers, deferrals and completed studies in an internal Access database. A dedicated CDER-wide PREA tracking system is under development.

FY 2003 performance is summarized in the following list:

  1. Complete review and action on 80% of pediatric supplements in response to a WR within 6 months: CDER reviewed and acted upon 17 of 17 (or 100%) of the pediatric supplements received within the 6-month timeframe.
  2. Work with NIH to publish the initial Priority List of Drugs and work with NIH to update the list: NIH published the initial Off-Patent Drug List on 1/21/03 and an update on 8/13/03
  3. Issue WR's for the study of on-patent drugs in the pediatric population: FDA issued 28 WR's for on-patent drugs and 56 amendments to existing WR's
  4. Make exclusivity determinations once final study reports are submitted:
    • Final study reports submitted: 23
    • Exclusivity Determinations: 21
    • Exclusivities Granted: 19
  5. Determine final pediatric label changes, and disseminate information
    • Labels Changed: 21
    • Information Disseminated: 2 AAP News
    • Article published: 4 abstracts published; 1 JAMA article published; 2 Pediatric Advisory Subcommittee meetings held; Newborn Workshop Planning meeting; 27 other outside presentations
  6. Issue 6-8 WR's for off-patent drugs:FDA issued 7 off-patent WR's
  7. Work with NIH to issue RFP's for contracts for the study of drugs (outlined in a WR): In response to the BPCA, the Agency has undertaken numerous collaborative activities with the Institute of Medicine (IOM), the National Institutes of Health (NIH) and the American Academy of Pediatrics (AAP). NIH and FDA have developed a process for transforming written requests (WR's) into requests for proposals (RFP's) as well as collaborating on the development of the annual Priority List of Drugs.
  8. Publish 5-7 RFP's: NIH has published 4 RFP's and published the initial Off-Patent Drug List on 1/21/03 and an update on 8/13/03.
  9. Track all applications that would have triggered the pediatric rule, to include waivers, deferrals, and completed studies.The Pediatric Rule was enjoined by the US District Court on October 17, 2002. However, the applications that would have triggered the Pediatric Rule were entered into a pediatric tracking database.

    For FY 2003, the target for this performance goal included several measures within the Pediatric program. Despite the fact that all of the work required to meet this performance goal was accomplished by FDA, the target to work with NIH to issue RFP's for contracts for the study of drugs outlined in a written request and publish 5-7 RFP's was not met, as NIH only published 4 RFP's The process of publishing RFP's is completely managed by NIH and therefore, the publication of an RFP is not under FDA's control.

  • Data Sources and Issues: Pediatric Exclusivity Database, Pediatric Page database, and CHCA inpatient database. The Pediatric Exclusivity Database tracks all data regarding pediatric exclusivity as mandated by FDAMA and reauthorized by BCPA. Specifically, this database tracks the number of WR's issued and the number of products for which pediatric studies have been submitted and for which exclusivity determinations have been made. The Pediatric Page database captures all information regarding waivers, deferrals, and completed studies for applications that are subject to the Pediatric Research Equity Act.

3.  Improve the efficiency and effectiveness of the generic drug review program to ensure safe and effective generic drug products are available for Americans. (12003) (Formerly: Ensure safe and effective generic drugs are available to the public.)

  • Context of Goal: Generic drugs are much appreciated for their cost-effectiveness. According to the Congressional Budget Office, they save consumers an estimated $8 billion to $10 billion a year compared with the price of trade-name products. The basic requirements for approval of generic and trade-name drugs are the same as new drug approvals, although the generic drug manufacturer does not need to repeat the safety and efficacy studies conducted by the developer of the original product. Prior to approval, generic drug sponsors are required to demonstrate bioequivalence to the innovator drug product by showing that the active ingredient in their product is absorbed at a rate and extent similar to the innovator counterpart. The approval time is measured from the date the application is received to the date a major action, either an approval or not approvable, is reached.

    This performance goal is an interim step toward achieving the Agency long-term outcome goal to reduce average time to marketing approval or tentative approval for safe and effective new generic drugs. The target for the long-term outcome goal is to reduce the average FDA time to approval or tentative approval for the fastest 70% of original generic drug applications by 1.5 months. The FY 2006 target involves making interim progress toward that target by decreasing the average time by 0.5 months.

    Targets for FY 2003 - 2005 for this performance goal involve progressively increasing the percentage of generic drug applications reviewed and acted upon within six months after submission. Reviewing and acting upon more applications in less time should help drive down the average approval time. In FY 2002, the median approval time for generic drugs was 18.3 months. For FY 2003, the median approval time was down by one month to 17.3 months and down another month to 16.3 months for FY 2004.

  • Performance: FDA exceeded its goal for FY 2004 by acting on 91 (estimated) percent of 563 original applications. (Final figures for FY 2004 will be available after March 31, 2005.) FDA also exceeded its goal in FY 2003 by acting on 90 percent of 449 original applications. In FY 2002 CDER continued to improve the generic drug review process and educate various audiences in the safe and effective use of generic drugs as a substitute to their brand-name counterparts. Increased staff has provided the Office of Generic Drugs with scientific managers and experts, including a Director of Science, several chemistry reviewers and managers, a Medical Officer, and regulatory management officers. Furthermore, compliance and legal support to the Office of Generic Drugs was expanded. The increased staff was critical in reducing review times for ANDA's/generic drug applications and granting approval as quickly as possible. With the requested increases for FY 2005, FDA plans to hire additional reviewers and other staff to accelerate the review and approval of Abbreviated New Drug Applications. In addition, we plan to improve the review of ANDA's without sacrificing product quality to allow the Agency to reach its goal of reviewing 90 percent in FY 2005 within six months after submission. We also plan to hire additional inspectors to increase inspections of domestic and foreign firms associated with generic drug production, an activity critical to reducing total approval times; and, increase coverage of imported generic drugs to better monitor the quality of finished drug products and bulk drug substances from overseas. Additionally, the increase will also be used to conduct research that will allow us to address specific scientific questions regarding bioequivalence and chemistry of generic products. This research will be directed at evaluating ways to enable approval of generic drugs in areas that currently lack generic alternatives, such as inhalational or topical drug products.
  • Data Sources and Issues: COMIS, NDE/MIS: FDA has a quality control process in place to ensure the reliability of the performance data in COMIS. This process provides information on how document room contractors and the Records Management Team quality control this data.

4. Improve the efficiency and effectiveness of the over-the-counter (OTC) drug review program to ensure a safe and effective drug supply is available. (12048) (Formerly: Increase the number of drugs adequately labeled available for OTC use)

  • Context of Goal: Over-the-counter (OTC) drugs play an increasingly vital role in America's health care system. The trend to self-medicate has increased greatly in recent years as health care costs have risen and consumers want to be empowered to treat minor ailments with OTC drug products. However, safety, effectiveness, and proper labeling have not always been characteristic of OTC drug products in the United States. FDA's goal by 2010 is to complete its existing review of OTC drug products, to have considered a number of key foreign drugs for marketing in the United States, and to have considered a number of key potential "prescription (Rx)-to-OTC" switches.

    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 7-10 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.

  • Performance: FDA exceeded its goal by completing review and action on 100% of Rx-to-OTC switch applications within 10 months of receipt and making significant progress on 8 OTC monographs (vaginal contraceptive drug products containing Nonoxynol 9; antacids; internal analgesic, antipyretic, and antirheumatic; laxative; cold, cough, allergy, bronchodilator, and antiasthmatic; miscellaneous external drug products such as dandruff control, seborrheic dermatitis, and psoriasis; diaper rash; and sunscreen). In FY 2003 eleven new OTC drug products were approved and seven had approvable actions. FDA acted upon 100% of Rx-to-OTC applications within 10 months of receipt in FY 2003 and made significant progress on 6 OTC monographs (sunscreen, internal analgesic, healthcare antiseptics, laxative, poison treatment, and oral health care). The expansion of the OTC drug review to evaluate foreign OTC drugs is expected to increase switch requests in the near future. While CDER is hoping for a 50 percent increase in applications, we do not control the number of applications submitted. For this reason, we do not believe a specific number in this goal is appropriate. FDA recognizes that some of these switch requests involve issues of "OTCness" - determination that the drug is appropriate for OTC use and developing appropriate labeling and other information (such as was done for OTC stop smoking aid products) for safe and effective consumer use of these products without the intervention of a health care professional.
  • Data Sources and Issues: CDER uses the Center-wide Oracle Management Information System (COMIS) and New Drug Evaluation/Management Information System (NDE/MIS). FDA has a quality control process in place to ensure the reliability of the performance data in COMIS. Published monographs that establish acceptable ingredients, doses, formulations, and consumer labeling for OTC drugs.

5. Create state-of-the-art information and knowledge management systems and practices to move to a paperless environment. (12051)

  • Context of Goal: The use of current technology will allow CDER to receive and review regulatory submissions more efficiently. In order to move to a paperless environment in an efficient and cost effective manner, we must develop standards for submission.
  • Performance: Due to the increase in electronic submissions since 1997, there has been a significant decrease in the average number of paper volumes per NDA submissions. CDER has been receiving an increasing volume of regulatory submissions in electronic format. In FY 2004, CDER processed 5,849 submissions. In that year, CDER received 134 new NDA's of which 77.6% had electronic components. CDER exceeded its target for ANDA's with electronic components. In FY 2004, CDER processed 571 new ANDA's of which 72.5% had electronic components. In FY 2003, CDER processed 3753 submissions which was over 100 percent of the FY 2001 submission rates. In that year, CDER received 120 new NDA's of which 66 percent had electronic components. The number of totally electronic submissions was 9 percent for FY 2003, and new supplements received with an electronic component was 24.1 percent for the year. CDER began receiving electronic ANDA's toward the end of 2002. In FY 2003, CDER processed 287 submissions. In that year, CDER received 444 new ANDA's of which 37 percent had electronic components.
  • Data Sources and Issues: The CDER Electronic Document Room.

6. 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. (12045)

  • Context of Goal: The first therapy for those exposed to a biological, chemical, or radiological/nuclear agent is often a drug. FDA has been taking an aggressive and proactive approach to getting information on medical countermeasures into the labeling of already approved drugs. For example, gentamicin has not been FDA-approved for plague, yet is also widely recommend as a preferred therapy by experts. Human clinical trial data are needed to demonstrate safety and efficacy for specific treatments and to identify new therapeutic drug options.

    In the Federal Government's response to various agents of mass destruction, drugs will be mobilized from the CDC's Strategic National Stockpile (SNS). However, not all drugs in the SNS are FDA-approved for Counterterrorism uses. Identification of these deficits including development of a plan to address these deficits will move the Public Health Service closer to a goal of labeling all drugs that reside in the SNS for Counterterrorism uses.

  • Performance: Measurements of performance for the FY 2004 targets for the Counter Terrorism performance goal were:
    1. Develop list of high priority products for countermeasures and a plan to periodically review and update list: CDER developed and maintains a list of products for uses against radiological/nuclear, chemical, and Category A biological agents. It includes all products of which we are aware and identifies the stage of development and other relevant information. It also includes products that are FDA-approved for other indications but have potential for development for counter-terrorism (CT) uses, as well as products that are FDA-approved for CT uses. Four new drug and 16 generic drug applications were approved with counter-terrorism indications:

      Radiation: Radiogardase (insoluble Prussian blue) capsules were approved to treat people internally contaminated with radioactive Cesium-137 or Thallium, October 2003. Pentetate calcium trisodium injection (Calcium DTPA) and pentetate zinc trisodium injection (Zinc DTPA) were approved for the treatment of internal contamination with plutonium, americium, or curium, August 2004.

      Chemical: The Pediatric AtroPen infant atropine autoinjector was approved, September 2004. The atropine autoinjector products automatically inject a potentially life-saving antidote into people poisoned by nerve agent. The pediatric and now infant autoinjectors provide this same benefit in a dose and dosage form suitable for children as young as 6 months.

      Biological: In 2004, fifteen new generic drug products for ciprofloxacin were approved and new labeling for Procaine PenG was approved, with the indication of prevention of inhalational anthrax post-exposure.

      With the passage of the National Defense Authorization Act for Fiscal Year 2004, CDER took a proactive stance to address potential products for use under the Emergency Use Authorization (EUA) provisions by reviewing the SNS formulary list and prioritizing several products as candidates for EUA evaluation. A working group drafted a review template as well as processes and procedures for handling EUA submissions.

    2. Develop guidance(s) for industry and stakeholders related to evaluating products under development or for which there is a need to develop products for medical countermeasures: In March of 2004, CDER finalized and published the Guidance for Federal Agencies and State and Local Governments: Potassium Iodide Tablets Shelf Life Extension. CDER also published the Draft Guidance for Industry: Vaccinia Virus — Developing Drugs to Mitigate Complications from Smallpox Vaccination, has evaluated comments received, and is in the process of finalizing the guidance.

      The Draft Guidance for Industry: Developing Drugs to Treat or Prevent Smallpox (Variola) Infection - Preparing an IND was completed and began the clearance process.

      In March 2002, CDER published the Draft Guidance for Industry - Inhalational Anthrax (Post-Exposure) Developing Antimicrobial Drugs. In 2004, revised the guidance to address the comments received.

      CDER and CBER are collaborating on a draft Guidance for Industry: Inhalational Anthrax (Symptomatic) - Developing Therapeutics that Target Anthrax Toxin. Initiation of this guidance followed the June 2004 public workshop "Strategies for Developing Therapeutics that Directly Target Anthrax and its Toxins." CDER, CBER, NIH, DARPA, USAMRIID, and CDC collaborated on and participated in this workshop, held at the NIH's Natcher Auditorium.

      CDER also drafted Guidance for Industry: Development of Decorporation Agents for the Treatment of Internal Radioactive Contamination. The guidance has been completed and is currently undergoing review to complete final sign off prior to publication.

      CDER also participated in drafting the Agency guidance Emergency Use Authorization of Medical Products, to inform industry, government agencies, and FDA staff of the Agency's general recommendations and procedures for issuance of emergency use authorizations (EUA) under the National Defense Authorization Act for Fiscal Year 2004 and subsequent enactment of the Project BioShield Act of 2004. The text of the draft guidance has been completed and is currently undergoing review at the DHHS level.

    3. Facilitate drug development of countermeasures for plague; In FY 2004, CDER continued to develop the African green monkey (AGM) model of pneumonic plague and apply it to efficacy determination of 5 approved antibiotics (gentamicin, ciprofloxacin, levofloxacin, ceftriaxone, and doxycycline). Most of the requisite pharmacokinetic (PK) and toxicology studies have been completed. Two separate studies of gentamicin at different doses (the second study used a humanized dose) have been conducted, with the next antibiotic, ciprofloxacin, about to begin. Discussions with NIH and USAMRIID are ongoing concerning the added value of studying streptomycin in this model. Streptomycin is approved and widely used to treat plague, but has never undergone formal testing.

      CDER worked with the CDC to finalize establishment of the protocols and infrastructure for the human plague studies in Africa. Enrollment began August 30, 2004. Concomitantly, a rapid plague diagnostic test kit will be evaluated, this is a collaborative effort with CDRH.

    4. Review existing safety data for ribavirin for viral hemorrhagic fevers; In FY 2004, CDER completed a review of the adverse events reported on the use of ribavirin as an emergency IND and completed a review of adverse event data from Canada on SARS patients given IV or oral ribavirin.
    5. Intra-Agency Working Group to facilitate Radiological/Nuclear medical countermeasure development:
    6. In FY 2004, CDER organized a Working Group comprised of members from FDA, NIH, industry, and academia to design and implement a development program to gain approval for existing, licensed biological cytokines for an acute radiation syndrome (ARS) treatment indication using the Animal Efficacy Rule. The WG has designed a development program that includes review of existing animal efficacy data as a "first" animal species and the conduct of a pivotal nonhuman primate efficacy trial as the second species. A draft protocol is presently circulating for comments. A review of canine data for a candidate drug has been completed and is planned for submission to the review division. In addition, CDER's activities included:

      • Representing the Agency in an interagency working group chaired by NIH/NIAID and charged with identifying promising radiological/nuclear countermeasures that were early in development and prioritizing them for purposes of funding. This activity is ongoing.
      • Holding pre IND meetings with a total of 8 sponsors of potential radiological/nuclear countermeasures in very early stages of development.
      • Organizing and chairing an inter-Center Nuclear/Radiological Therapeutic Countermeasures Working Group where product development issues could be shared. Meetings were frequently held jointly with the inter-Center Animal Efficacy Rule Working Group, to discuss specific animal models of human disease to facilitate product development.

      Measurements of performance for the FY 2003 targets for the Counter Terrorism performance goal were:

      Develop Guidance's for Industry on developing antiviral drugs:

      • CDER completed the Draft Guidance for Industry: "Vaccinia Virus - Developing Drugs to Mitigate Complications from Smallpox Vaccination" and began the clearance process. This draft guidance was published March 2004.
      • CDER continued work on the Draft Guidance for Industry: "Developing Drugs to Treat or Prevent Smallpox (Variola) Infection - Preparing an IND."

      Identify and begin to address labeling gaps in the therapeutic armamentarium:

      CDER addressed such gaps by :

      • Approving new drug applications for medical countermeasures for use against terrorist agents:
        • Radiogardase (insoluble Prussian blue) capsules for treatment of exposure to radiation contamination from cesium-137 or thallium.
        • Pyridostigmine tablets for exposure to Soman nerve gas.
        • Lower doses of the AtroPen Autoinjector (atropine) for use in pediatric patients.
        • Doxycycline products added information on use for post-exposure prophylaxis of inhalational anthrax.
      • Evaluating available data to permit Federal Register Notices of finding of safety and efficacy and announcing the availability of Guidance's to Industry to encourage submission of new drug applications for Prussian Blue and Calcium and Zince-DTPA.
      • Collaborating with other federal agencies on human and animal studies of plague.
        • CDER continued to support the CDC's human plague trials in Uganda and Madagascar for the evaluation of the efficacy of gentamicin for the treatment of plague and of plague diagnostic kits.
        • CDER, NIAID, and USAMRIID continued efforts to evaluate the efficacy of several antibiotics in pneumonic plague in non-human primates under an Inter-Agency Agreement with NIAID/NIH and USAMRIID:
          • The natural history study of pneumonic plague in an African green monkey model was completed. Data from this study were used to determine the time of drug intervention in the study of gentamicin efficacy for pneumonic plague in African green monkeys.
          • Pharmacokinetic and toxicology studies of gentamicin in African green monkeys were completed. Data from these studies permitted investigators to choose an appropriate gentamicin dose for the study of gentamicin efficacy for pneumonic plague in African green monkeys.
      • Reviewing data and addressing labeling revisions for antimicrobials used for post-exposure prophylaxis of inhalational anthrax.
      • Continuing support of contracts through the FDA Office of Women's Health to collect pharmacokinetic and safety information in special populations (i.e., pregnant women, lactating women, elderly) on antibiotics that could be used as countermeasures.
      • Continuing support of an ongoing contract with the American Academy of Pediatrics that generates and disseminates information for pediatric use of countermeasures.
      • Issuing contracts for databases looking at long-term antibiotic use focusing on the therapies in the Strategic National Stockpile.
      • Engaging in activities to facilitate availability of countermeasures in an emergency by
        • Participating in inter-agency subgroups and working groups of the Weapons of Mass Destruction Medical Countermeasures Subcommittee, which reports directly to White House offices. These groups provide and discuss information that may lead to development of requirements documents for medical countermeasures to be procured under BioShield or other discretionary funds for placement in the Strategic National Stockpile.
        • Developing requirements documents and acquisition papers for DHHS for consideration of funding and development of promising medical countermeasures.
        • Participating in the DHHS Anthrax Risk Management Working Group to address development of anthrax interventions for potential procurement under Project BioShield.
        • Collaborating with the CDC to form a Post-Event Surveillance Working Group (PESWG) to develop processes and methods to collect and review data on medical outcomes and adverse events following the use of medical countermeasures during a terrorist event.
      • Providing information to the public on the use of medical countermeasures, available at  http://www.fda.gov/cder/drugprepare/default.htm:
        • "How to Prepare Emergency Dosages of Doxycycline at Home for Infants and Children."
        • Updated "Frequently Asked Questions on Potassium Iodide (KI)."

      Expedite the review of protocols for investigational new radioprotectant drugs;

      • CDER formed an Intercenter Nuclear/Radiologic Countermeasures Working Group to facilitate development of countermeasures.
  • Facilitate human clinical trials.

    • CDER continued to support the CDC's human plague trials in Uganda and Madagascar by establishing a Data Monitoring Committee for the oversight of the trials, continuing collaboration with the CDC on protocol development, and providing funding through an Inter-Agency Agreement. Enrollment in studies to determine the efficacy of gentamicin is expected to begin Fall 2004.
    • CDER and CDRH collaborated with the CDC on developing the protocol for the efficacy evaluation of diagnostic kits for plague, to be used in the CDC's human plague studies. CDER provided funding to support these evaluations.

    Additional counterterrorism activities performed by CDER included:

    • CDER provided some of the funding, through an Inter-Agency Agreement with NIAID, for a grant for the development of an oral product for smallpox treatment.
    • CDER provided some of the funding, through an Inter-Agency Agreement with NIAID, for a contract to evaluate animal models used to study Viral Hemorrhagic Fevers.
    • FDA published the "Draft Guidance for Federal Agencies and State and Local Governments: Potassium Iodide Tablets Shelf Life Extension." The final guidance was posted in March 2004.
    • FDA, CDC, and the Department of Homeland Security continued to address issues on procurement and use of products in the Strategic National Stockpile.
    • Data Sources and Issues: CDC/DHS Strategic National Stockpile (SNS) program, database from Department of Energy/REAC/TS (Oakridge), published Guidance's for Industry, published Federal Register Notices, CDER internet site  http://www.fda.gov/cder/drugprepare/default.htm.

7. Improve the Safe Use of Drugs in Patients and Consumers.(12007)

  • Context of Goal: This performance goal supports the Agency patient and consumer safety outcome goal to reduce adverse drug events related to medication dispensing and administrative errors (e.g., through initiatives such as product bar-coding). The Agency's Long Term Outcome Goal is to reduce these adverse events by 11% in 50% of US hospitals by FY 2008. The performance targets for FY 2004, 2005, and 2006 for this performance goal are interim steps toward accomplishing the long-term Agency goal. The targeted increase for the Office of Drug Safety for FY 2006 will directly support performance toward the 06 target.

    CDER uses a number of post-marketing risk assessment approaches to ensure the continued safe use of drug products and therapeutic biologics. Yet, approximately 1.3 million patients each year are injured from medical therapy with up to two thirds of these events due to medical management errors. Costs from these medical errors range from $37 to $50 billion annually. The Institute of Medicine estimates that as many as 98,000 Americans die annually as a result of preventable medical errors and the proliferation of new products may increase this number. In fiscal year 2002, FDA received 321,709 reports of suspected drug-related adverse experiences. Forty percent of these represented serious and unexpected experiences. Through the FDA Medical Products Reporting Program, MedWatch, healthcare professionals and consumers are encouraged to report serious adverse events and product problems to FDA, the manufacturer, or both. Reports of deviations from Good Manufacturing Practices that occur during the manufacturing, shipping, or storage of prescription or OTC drug products are sent to the FDA's Drug Quality Reporting System (DQRS). FDA receives medication error reports on marketed human drugs and maintains a central database within the DQRS and AERS for all reports involving a medication error or potential medication error. CDER puts substantial effort into reviewing adverse event and medication error reports to identify serious or potentially serious outcomes that might be avoided by modifying the labeling or packaging or other means. CDER's Adverse Event Reporting System (AERS) is an important risk assessment database essential for identifying potential safety signals and monitoring adverse experience reports. When a potential safety signal is detected, safety evaluators consult with product reviewers, including medical officers, and epidemiologists, to review available data, put the signal in context, and consider risk management options. FDA may decide to disseminate risk information, such as through "Dear Health Care Professional" letters, and may initiate regulatory action.

    The targeted increase for the Office of Drug Safety for FY 2006 will directly support performance toward the 06 target. CDER expects to use these funds to increase the number of staff with expertise in critical areas such as risk management, risk communication, and epidemiology. Further, CDER plans to use these funds to increase access to a wide range of clinical, pharmacy and administrative databases. To adequately and appropriately assess the safety of drugs as they are used, FDA needs access to externally managed databases. Due to the highly fragmented healthcare system in the United States, there is no single healthcare database that the Agency can rely upon to widely monitor drug adverse events. As each drug has its own indication(s) that may result in its differential use in different populations, it is essential that the FDA have access to a wide range of databases to adequately assess drug safety.

  • Performance: Several areas were targeted in FY04. The first is periodic safety reports submitted electronically. In FY03 9,710 Periodic ADE reports were submitted electronically. In FY04 24,189 Periodic ADE reports were submitted electronically, an increase of 149% relative to FY03. (The extent to which the Center tracks electronic submission of PSUR's is unclear; precise information about the number of electronically submitted PSUR's is currently unavailable).

    Continued work progresses on guidance for industry on risk management. Concept papers on good risk assessment, risk management, and pharmacovigilance practices have been published and discussed at April 2003 public meetings. The public comment period for these concept papers closed in May 2003. Working groups assimilated comments from the public meetings and from the docket and prepared the draft guidance. All three drafts published in May 2004, publication of the final guidance is taking longer than expected due to clearance delays.

    Enhancing the Adverse Event Reporting System is a top priority. Organization and Design Planning (ODP) sessions were held to review and summarize the business needs for adverse event reporting. Based on the ODP sessions and current AERS requirements, the program worked to draft and publish a Request for Information (RFI). The RFI outlines the programmatic and high level computer system requirements for the major AERS upgrade; one of which is enhanced medication error capture and analysis. The RFI and high-level requirements documents have been submitted to the FDA contract office. Publication is anticipated by January 10, 2005. Our plan shows that the vendors have until February 4, 2005 to respond to the RFI. We will review the responses and by February 25, 2005, decide our direction for developing the "new" AERS.

    FDA is encouraging industry to submit ADE reports electronically. Two meetings (October and April) focusing on electronic reporting were held with approximately 25 participating manufacturers to further promote and advance the conversion from paper to electronic submission of AE reports. Program representatives have also lectured at external meetings on the benefits of and need for electronic safety reporting. In FY03, 35,759 ADE reports were submitted electronically. In FY04, 69,111 ADE reports were submitted electronically, an increase of more than 90% relative to FY03.

  • Data Sources and Issues: CDER uses information from its adverse experience reporting system and its data quality reporting system for sources.

8. Give consumers and health professionals more easily understandable, accessible, timely, and accurate prescription and OTC drug information. (12027)

  • Context of Goal: This goal was dropped for FY 2005 and 2006. This performance goal directly supports the Agency Strategic Goal for Better Informed Consumers. There is increasing recognition that marketed drugs can lead to harm as well as benefit. Drug-related injuries and deaths can be reduced by creating a more educated public through expanded outreach activities and collaborative efforts with academia, professional societies, and health organizations. The specific subjects of FY 2004 education campaigns will be determined as issues and events reveal themselves closer to FY 2004. There are several electronic initiatives being undertaken by FDA over the next several years that will significantly improve our ability to provide medical to consumers and health professionals. These systems include an Electronic Labeling Information Processing System (ELIPS), Medication Information Databases for new drug applications (MedID), and an FDA/NLM public Ingredient Dictionary.
  • Performance: In FY 2004, public education campaigns for Acetaminophen/Liver Warning and NSAIDS GI Bleeding Warning were both completed. CDER also launched the following 3 education campaigns during that same time period:
    • Take Precautions When Using Sedatives: The goals for the public education campaign include generating public awareness about the potential risks of using certain medicines while driving or operating heavy machinery; and helping consumers understand certain labels on their medicines.
    • Misuse and Abuse of Rx Medicines by Older Adults: CDER and the Substance Abuse and Mental Health Services Administration developed and executed an educational campaign to inform older adults and other consumers of the consequences of misusing and abusing prescription medications, and available treatment options.
    • Read the Label: Over-the-Counter Pain Relievers: Due to an increased use of over-the-counter medicines, consumers run the risk of taking too many products that contain the same active ingredients. Since some active ingredients can be in a number of products, this campaign stresses the need for consumers to read the label and ask the advice of a healthcare professional when unsure about the use of any medicine, especially pain relievers.

    The activities involved in this target are a part of FDA's role in a multi-Agency effort known as the "DailyMed initiative". Conceptually, DailyMed will be an electronic repository for up-to-date medication information and will improve patient safety through improved access to medication information. DailyMed is a collaborative project involving the FDA, NLM and VA. The information flow required for the success of DailyMed involves medication manufacturers and distributors collaborating with the FDA to maintain detailed information about their products in a form called Structured Product Labeling (SPL). SPL is structured information about a medication contained in an XML file. Up-to-date SPL for each product will be transmitted to the NLM on a daily basis. NLM will provide the SPL along with other medication information in an electronic repository called the DailyMed. Healthcare information suppliers will be able to use the information from this repository in their computer systems, allowing providers, patients and the public access to reliable, up-to-date information on the medications they use. The objective of this project is to create the environment that will allow the FDA to generate up-to-date, reliable SPL for all drug products marketed in the United States. Future phases can potentially concentrate on other FDA regulated products including vaccines, animal drug products, dietary supplements, and medical devices. In FY 2004, FDA created the "SPL Program", an information technology initiative to create a technological environment that will enable FDA to reliably generate up-to-date SPL for all drug products marketed in the U.S. This program encompasses:

    • An Electronic Labeling Information Processing System (ELIPS), a repository and application for the receiving, validating, and transmitting SPL with tools to support labeling review; and
    • The Substance Registration System (SRS) which will be used to generate and maintain Unique Ingredient Identifiers (UNII) for product ingredients.
    • Data Sources and Issues: Approval Letters and the Labeling Text or Final Printed Label (FPL) for new drugs; Consumer Drug Information Sheets for New Molecular Entities (NME's); the program indicated that the following information on the processing procedures for this data is reliable and of sound quality. The information demonstrates that the appropriate quality control practices are in place.

9. Improve the capability and efficiency of pharmaceutical development and manufacturing. (12016)

  • Context of Goal: For FY 2003, this goal focuses on two important related activities that will improve the capability and efficiency of pharmaceutical development and manufacturing: the Product Quality Research Institute (PQRI) and the Process Analytical Technology (PAT): PQRI is an effort between the FDA's Center for Drug Evaluation and Research (CDER), the pharmaceutical Industry and academia. The purpose of PQRI is to conduct research on identified projects to establish better testing methods, standards, and controls for assessing product quality and manufacturing and management processes to look at risk/benefit of changing certain policies and requirements. This knowledge aids the Agency in developing consistent and reasonable requirements for product quality information in regulatory filings as a part of our risk management activities. Process Analytical Technologies (PATs) are systems for continuous analysis and control of manufacturing processes based on real-time measurements, or rapid measurements during processing. Measurements are made of quality and performance attributes of raw and in-process materials and processes to assure acceptable end product quality at the completion of the process. PATs involve processes of analytical chemistry, information management tools, feedback process control strategies, and product and process design and optimization strategies.

    The focus of this performance goal for FY 2004 and 2005 is on the Agency's current good manufacturing practices (cGMP) initiative. On August 21, 2002, FDA announced a major new initiative on regarding pharmaceutical manufacturing, "Pharmaceutical GMP's for the 21st Century: A Risk-Based Approach." The program has several ambitious objectives. One is to ensure that regulatory review and inspection policies are based on state-of-the-art pharmaceutical science and to encourage the adoption of new technological advances by the pharmaceutical industry. FDA will determine the best pathway to better integrate advances in quality management techniques, including quality systems approaches, into the Agency's regulatory standards and systems for the review and inspection processes. Additionally, risk-based approaches, that focus both industry and agency attention on critical areas, will be implemented. Finally, enhancements to the consistency and coordination of Agency drug quality regulatory programs will be made. Significant advances in the pharmaceutical sciences and in manufacturing technologies have occurred over the last two decades. While this knowledge has been incorporated in an ongoing manner into FDA's approach to product quality regulation, the fundamental nature of the changes dictates a thorough evaluation of the science base to ensure that product quality regulation not only incorporates up-to-date science, but also encourages further advances in technology. Although Americans have the highest quality of drugs in the world, the processes used to produce some of them are outdated. An increasing trend of manufacturing-related problems, such as recalls, disruptions of manufacturing operations, and the loss of availability of essential drugs has affirmed CDER's role as a catalyst for this initiative. Implementation of modern technology into the manufacturing process will produce the same or higher quality standards while reducing the workload for Industry and for FDA and ensuring the highest quality drug products for American consumers. More than 40 years ago, Congress required that all drugs be produced in accordance with current Good Manufacturing Practice (cGMP). This requirement was intended to address significant concerns about substandard drug manufacturing practices by applying quality assurance and control principles to drug manufacturing.

  • Performance: Key activities toward accomplishing the performance goal for improving the capability and efficiency of pharmaceutical development and manufacturing are associated with the current Good Manufacturing Practices (cGMP) Initiative. On February 20, 2003, the Food and Drug Administration (FDA) released its progress report on a major initiative concerning the regulation of drug product quality. The two-year program, launched on August 21, 2002, applies to human drugs and biologics and veterinary drugs and has several objectives. One is to ensure that regulatory review and inspection policies are based on state-of-the-art pharmaceutical science and to encourage the adoption of new technological advances by the pharmaceutical industry. FDA is working toward integrating advances in quality management techniques, including quality systems approaches, into the Agency's regulatory standards and systems for the review and inspection processes. Additionally, implementation of risk-based approaches, that focus both industry and agency attention on critical areas are underway. Lastly, the Agency is committed to enhancing the consistency and coordination of its drug quality regulatory programs.

    FDA received valuable input during the April 2003 inaugural scientific workshop that was held with stakeholders in Washington, DC. Based on the input of this workshop, as well as the progression and evolvement of the initiative over the past year, new working groups have been formed and some of the original working groups have been realigned. These groups are shaping and implementing the initiative as overseen by the FDA cGMP Steering Committee.

    Actual performance toward the FY 2004 targets is provided below:

    • Develop a Quality Systems framework for ensuring Pharmaceutical quality: The quality system framework document was officially adopted by the FDA Management Council on March 18, 2004;
    • Publish draft guidance for cGMP quality system principles for comment: FDA developed draft guidance for three separate cGMP issues - all of which support quality system principles;
    • Begin designation of specialized staff to form a Pharmaceutical Inspectorate (PI): FDA determined the staff who would form the PI and began training those staff;
    • Pilot a risk-based site selection model for inspection: CDER developed the risk-based model for site selection in FY 2004 and plans to pilot it in FY 2005

    Actual performance toward the FY 2003 targets is provided below:

    • PAT - Present during 1 trade meeting and 2 conferences: CDER is utilizing the Process Analytical Technology (PAT) Initiative to provide a science based regulatory framework. Industry has been hesitant to implement new technologies because of unknown factors that may arise under the regulatory environment in which it operates. CDER has formed a PAT subcommittee to the Advisory Committee for Pharmaceutical Science. A cadre of PAT specialists from the Office of Regulatory Affairs (ORA) and CDER has been established and trained. In FY 2003, FDA presented during 1 trading meeting and discussed initiative during two conferences. PQRI
    • Submitted comments regarding the blend uniformity document prepared by PQRI and participated in two PQRI Work Groups.
    • Meet with 2 potential applicants: Met with 2 potential applicants.
    • Prepare a draft guidance. Draft guidance was issued in August 2003.
    • PQRI - Move toward 25% of completion for each of the three projects. (Initiate draft blend uniformity guidance in response to PQRI comments and participate in 2 PQRI work groups to develop recommendations): FDA conducted three laboratory research programs and performed the corresponding research in connection with the mission of PQRI: Oral Biopharmaceutics, Drug Product, and Drug Substance
    • Finalize eCTD guidance. e-CTD: The FDA has worked with their partners in the International Conference on Harmonization (ICH) on the Common Technical Document (CTD). The CTD provides the harmonized format and content for new product applications in the US, EU, and Japan. While the CTD is based on a paper paradigm, the FDA has also worked with their partners in ICH to develop the Electronic Common Technical Document (eCTD) to provide the electronic transmission of CTD applications from applicant to regulator. The eCTD specification is ready for implementation as it has reached Step 4 in the ICH process. For the FDA, the eCTD format will replace many of the current electronic submission formats and allow the electronic transmission of applications that currently do not have an electronic solution. Leveraging a common technology across submission types will enhance the review process by allowing the FDA to build a common infrastructure and user interfaces for multiple submission types.
  • Data Sources and Issues: Guidance documents. Relevant materials may be found on our web site.

 

CBER's Performance Goals

Performance Goals Targets Actual Performance Reference
1. 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. (13001)

Standard Applications within 10 months:

FY 06: 90%
FY 05: 90%
FY 04: 90%
FY 03: 90%
FY 02: 90%
FY 01: 70%
FY 00:50%
FY 99: 30%

Priority Applications within 6 months:

FY 06: 90%
FY 05: 90%
FY 04: 90%
FY 03: 90%
FY 02: 90%
FY 01: 90%
FY 00: 90%
FY 99: 90%

Standard Applications within 10 months:

FY 06:
FY 05:
FY 04: 9/05
FY 03: 100% of 4
FY 02: 100% of 6
FY 01: 100% of 5
FY 00: 100% of 10
FY 99: 100% of 5

Priority Applications within 6 months:

FY 06:
FY 05:
FY 04: 5/05
FY 03: 100% of 4
FY 02: 100% of 3
FY 01: 100% of 3
FY 00: 100% of 4
FY 99: 100% of 1

 4
2. 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. (13002)

Standard Applications within 10 months:

FY 06: 90%
FY 05: 90%
FY 04: 90%
FY 03: 90%
FY 02: 90%
FY 01: 70%
FY 00: 50%
FY 99: 30%

Priority Applications within 6 months:

FY 06: 90%
FY 05: 90%
FY 04: 90%
FY 03: 90%
FY 02: 90%
FY 01: 90%
FY 00: 90%
FY 99: 90%

Standard Applications within 10 months:

FY 06:
FY 05:
FY 04: 9/05
FY 03: 100% of 13
FY 02: 83% of 7
FY 01: 100% of 14
FY 00: 100% of 11
FY 99: 100% of 8

Priority Applications within 6 months:

FY 06:
FY 05:
FY 04: 5/05
FY 03: 100% of 2
FY 02: 100% of 4
FY 01: 100% of 2
FY 00: 100% of 2
FY 99: 100% of 2

4
3. Complete review and action 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. (13003)

Within 6 months:

FY 06: NA
FY 05: NA
FY 04: NA
FY 03: 90%
FY 02: 90%
FY 01: 90%
FY 00: 90%
FY 99: 90%

Within 4 months:

FY 06: NA
FY 05: NA
FY 04: NA
FY 03: 90%
FY 02: 90%
FY 01: 70%
FY 00: 50%
FY 99: 30%

Within 6 months:

FY 06:
FY 05:
FY 04:
FY 03: 99% of 598
FY 02: 98% of 486
FY 01: 94% of 410
FY 00: 97% of 349
FY 99: 96% of 218

Within 4 months:

FY 06:
FY 05:
FY 04:
FY 03: 99% of 303
FY 02: 99% of 222
FY 01: 95% of 186
FY 00: 92% of 241
FY 99: 93% of 259

4
4. Complete review and action 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. (13004)

Class 1 resubmissions within 2 months:

FY 06: NA
FY 05: NA
FY 04: NA
FY 03: 90%
FY 02: 90%
FY 01: 70%
FY 00: 50%
FY 99: 50%

Class 2 resubmissions within 6 months:

FY 06: NA
FY 05: NA
FY 04: NA
FY 03: 90%
FY 02: 90%
FY 01: 90%
FY 00: 90%
FY 99: 90%

Class 1 resubmissions within 2 months:

FY 06:
FY 05:
FY 04:
FY 03: 100% of 1
FY 02: 100% of 2
FY 01: 100% of 6
FY 00: 100% of 1
FY 99: 100% of 2

Class 2 resubmissions within 6 months:

FY 06:
FY 05:
FY 04:
FY 03: 100% of 11
FY 02: 100% of 13
FY 01: 100% of 10
FY 00: 100% of 8
FY 99: 100% of 12

 4
5. 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. (13005)

Complete Submissions:

FY 06: 90%
FY 05: 90%
FY 04: 90%
FY 03: 90%
FY 02: 90%
FY 01: 90%
FY 00: 85%
FY 99: 60%

Supplements:

FY 06: 90%
FY 05: 90%
FY 04 90%
FY 03: 90%
FY 02: 90%
FY 01: 90%
FY 00: 90%
FY 99: 90%

Complete Submissions:

FY 06:
FY 05:
FY 04: 11/05
FY 03: 100% of 5
FY 02: 100% of 5
FY 01: 100% of 7
FY 00: 100% of 12
FY 99: 100% of 10

Supplements:

FY 06:
FY 05:
FY 04: 11/05
FY 03: 100% of 530
FY 02: 99% of 469
FY 01: 99% of 417
FY 00: 100% of 559
FY 99: 99% of 780

 4

 

Note about Baseline Data: In several years of the program, performance (Baseline Data) exceeds the projected performance goals. The PDUFA III goals were set forth in letters from the Secretary of Health and Human Services to Congressional Committee Chairmen. FDA developed these goals in consultation with the pharmaceutical and biological prescription drug industries. "NA" means the goal is not applicable in that fiscal year.

The PDUFA application-review performance goals measure time to first action, not final action. The term "complete review and action on" is understood to mean the issuance of a complete action letter after the complete review of a filed complete application. The action letter, if it is not an approval, will set forth in detail the specific deficiencies and, where appropriate, the actions necessary to place the application in condition for approval. The performance goals and this definition were developed in consultation with the industry and Congress and are contained in the Secretary's commitment letter to the Chairman of the Energy and Commerce Committee of the House of Representatives, and the Chairman of the Labor and Human Resources Committee of the Senate. This definition enables to the Agency to approve only safe and effective products without having to issue not-approvable decisions on applications that are in some way not in condition for approval.

1. Complete review and action on 90% of standard original PDUFA NDA and BLA submissions within 10 months; and review and act on 90% of priority original PDUFA NDA/BLA submissions within 6 months of receipt. (13001)

  • Context of Goal: 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. Standard original BLA's are license applications for biological products, not intended as therapies for serious or life-threatening diseases. A priority BLA is a license application for a therapy to treat serious or life-threatening diseases.
  • Performance: CBER has met or exceeded these performance goals since 1994. These applications are tracked by year of receipt, which is the cohort year. The cohort-year review performance is not available until the prescribed review time, i.e., 10 months after receipt, is expired. In FY 2003, CBER exceeded its goal by completing review and action on 100% of 4 Standard applications within 10 months, and reviewing and acting on 100% of 4 Priority applications within 6 months. The FY 04 Performance data for standard applications will be available September 2005; the FY 04 Performance data for priority applications will be available May 2005.
  • Data Sources: CBER's Regulatory Management System

2. 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. (13002)

  • Context of Goal: The 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. A supplement is a change to an approved licensed product. An efficacy supplement provides information to FDA to modify the "approved effectiveness" in the labeling of a product such as a new indication, and normally includes clinical data.
  • Performance: CBER has met or exceeded most of these performance goals since 1994. In FY 2002, one standard efficacy supplement was overdue. These applications are tracked by year of receipt, which is the cohort year. The cohort-year review performance is not available until the prescribed review time, i.e., 10 months after receipt, is expired. In FY 2003, CBER exceeded its goal by completing review and action on 100% of 13 Standard PDUFA efficacy supplements within 10 months, and reviewing and acting on 100% of 2 Priority applications within 6 months. The FY 04 Performance data for standard efficacy supplements will be available September 2005, and the FY 04 Performance data for priority efficacy supplements will be available May 2005.
  • Data Sources: CBER's Regulatory Management System

3. Complete review and action 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. (13003)

  • Context of Goal: The 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. A supplement is a change to an approved licensed product. A manufacturing supplement provides FDA information relating to a proposed expiration date change, formulation revision, manufacturing process change, packaging change, or controls change. As directed by OMB, this goal was dropped in FY 2004 and 2005 in order to streamline the Performance Plan.
  • Performance: CBER has met or exceeded these performance goals since 1994. In FY 2003, CBER exceeded its goal by reviewing and acting on 99% of 598 PDUFA manufacturing supplements within 6 months of receipt, and reviewing and acting on 99% of 303 PDUFA manufacturing supplements requiring prior approval within 4 months of receipt.
  • Data Sources: CBER's Regulatory Management System

4. Complete review and action 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. (13004)

  • Context of Goal: 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. A resubmitted original application is a complete response to an action letter addressing all identified application deficiencies. Class 1 resubmitted applications are applications resubmitted after a complete response letter that include one or more of the following items: final printed labeling; draft labeling; safety updates; stability updates; commitments to perform Phase IV (postmarketing) studies; assay validation data; final release testing; a minor re-analysis of data; other minor clarifying information; or other specific information requested by the Agency. Class 2 resubmissions include any other items. As directed by OMB, this goal was dropped in FY 2004 and 2005 in order to streamline the Performance Plan.
  • Performance: These applications are tracked by year of receipt, which is the cohort year. In FY 2003, CBER reviewed and acted on 100% of 1 Class 1 resubmissions within 2 months, and reviewed and acted on 100% of 11 Class 2 resubmissions within 6 months.
  • Data Sources: CBER's Regulatory Management System

5. 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. (13005)

  • Context of Goal: Blood bank and source plasma applications are not covered by PDUFA. The non-PDUFA review resources in CBER are not protected from cuts as the PDUFA resources are by the PDUFA legislation. CBER's non-PDUFA review resources have been cut in recent years to meet unfunded pay raises, increased current service costs, and other budget actions.
  • Performance: These applications are tracked by year of receipt, which is the cohort year. In FY 2003, CBER exceeded its goal by reviewing and acting on 100% of 5 complete submissions within 12 months, and reviewing and acting on 100% of 530 supplements within 12 months after submission date. The FY 04 Performance data for complete submissions and supplements will be available November 2005.
  • Data Sources: CBER's Regulatory Management System

 

CVM's Performance Goals

Performance Goals Targets Actual Performance Reference

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

This goal is dependent upon a sustained level of base and user fee resources.

(14020)

Complete review and action on 90% of original NADA's& reactivations of such applications received in FY 2006.

FY 06: within 230 days.
FY 05: within 270 days.
FY 04: within 295 days.

FY 06:
FY 05:
FY 04: 10/05
 4

2. Complete review and action on 90% of all new animal drug applications and supplements received in FY 03 within 275 days; and complete review and action on 90% of all investigational new animal drug submissions received in FY 03 within 325 days.

(14017)

FY 06: NA
FY 05: NA
FY 04: NA

FY 03: Complete review & action on 90% of all new animal drug applications and supplements received in FY 03 within 275 days; and complete review & action on 90% of all investigational new animal drug submissions received in FY 03 within 325 days.

FY 02: Complete review and action on 50% of NADA's/ANADA'swithin 180 days of receipt.

FY 01: 75%
FY 00: 73%

FY 06:
FY 05:
FY 04: NA
FY 03: 99.3% - NADA's& supplements

(2,078 of 2,092)

98.5% - INAD's

(2,144 of 2,176)

FY 02: 67%

1932 of 2895

% completed on-time

FY 01: 47%

961 of 2044

% completed on-time

FY 00: 84%

1539 of 1841

% completed on-time

 4
3. Continue development, expansion and integration of the Staff College. (14018)

FY 06: NA

FY 05: NA

FY 04: Continue integration of LMS system w/Center and Agency infrastructure; continue to expand content of in-house programs.

FY 03: 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.

FY 02: Plan and design the option selected in Phase I.

FY 01: Initiate the development of a Staff College (Phase I: further needs assessment, feasibility studies, and analysis of alternatives).

FY 06:

FY 05:

FY 04: Goal accomplished through activities outlined in Performance text.

FY 03: Goal accomplished through activities outlined in Performance text.

FY 02: Completed plan and design of Phase I.

FY 01 : Initiated the development of a Staff College (Phase I).
4
4. 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. (14005)

FY 06: NA

FY 05: NA

FY 04: Post NARMS standard laboratory methods on the Internet to provide easy access by other laboratories conducting antimicrobial resistance research & background information for persons reviewing the NARMS results. 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 NARMS web site.

FY 03: 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 web site.

CY 02: Total: 12,000 Salmonella isolates

CY 01: Total: 12,000 Salmonella isolates

CY 00: Total: 6,000 Salmonella isolates - 2,000 (human), 4,000 (veterinary)

CY 99: Total: 6,000 Salmonella isolates - 2,000 (human), 4,000 (veterinary)

FY 06:

FY 05:

FY 04: Goal accomplished through various activities discussed under Performance text.

FY 03: Goal accomplished through various activities discussed under Performance text.

CY 02: Total 12,000 Salmonella isolates

CY 01: Total 8,899 Salmonella isolates - 1,671 (human); 6,795 (veterinary); 433 (retail meat)

CY 00: Total: 11,000 Salmonella isolates - 2,000 (human), 9,000 (veterinary)

CY 99: Total: 10,216 Salmonella isolates - 1,706 (human), 8,510 (veterinary)

1

 

1. Promote safe and effective animal drug availability ensuring public and animal health by meeting ADUFA performance goals including: complete review and action on 90% of original NADA's and reactivations of NADA's received during FY 2006 within 230 days. (14020)

  • Context of Goal: The Animal Drugs and Feeds Program initiated a user fee program upon passage of the FY 04 appropriation. The user fee program reflects the implementation of a five (5) year plan to improve the performance for animal drug review. The user fee program for animal drug review requires new animal drug applicants, sponsors, and establishments to pay a fee to expedite the review of their respective applications. The benefits provided by the user fee program include: shorter review times; a more predictable and stable review process; and, an overall reduction in drug development time.

    The FY 05 and FY 06 targets for Performance Goal 1 reflects performance measures consistent with the goals industry has agreed upon for user fees. The target represents one of the user fee goals and reflects the Center's move toward completion of 90% of specified new animal drug submission reviews within statutorily mandated time frames over a five-year period. This goal is dependent upon a sustained level of base and user fee resources.

    As mandated by the Federal Food, Drug and Cosmetic Act, a new animal drug may not be sold in interstate commerce unless it is the subject of an approved New Animal Drug Application (NADA). An approved NADA means the product is safe and effective for its intended use and that the methods, facilities and controls used for the manufacturing, processing and packaging of the drug are adequate to preserve its identity, strength, quality and purity.

    When a new animal drug application is submitted, CVM evaluates the information contained or referenced in the application. A determination is made whether the application is approved or not approved. The sponsor receives a letter informing them either of the approval or describing the deficiencies in the application. The "days to review" refers to the time it takes to review and take an action on the original submission, or if needed, on subsequent recycles. This is different from total approval time which is the time it takes from the original receipt of the application until it is finally approved, which may take more than one review cycle. This includes the time we spend reviewing the application in each of the review cycles plus the time taken by the sponsor to respond to the issues raised in the not approved letter(s) and resubmit the application for review.

    FDA is encouraging sponsors to use the phased review process for new animal drug applications. An Investigational New Animal Drug (INAD) file or submission is established at the request of the sponsor to archive all sponsor submissions for a phased drug review including: request for interstate shipment of an unapproved drug for study, protocols, technical sections, data sets, meeting requests, memos of conference and other information. Phased review has removed a common bottleneck caused by the fact that a sponsor had to wait until all technical sections were reviewed before FDA would render an opinion on the sufficiency of an application. As a result, the technical section in the application that required the longest review could stymie progress on other sections. Under phased review, sponsors can coordinate submission of each technical section as the work for that section is completed. In addition, the direct review program, when linked with phased review, has resulted in significantly improved and more interactive communication between sponsor and reviewer, enabling a more efficient and logical review process.

  • Performance: "Baseline" performance for Goal #1 (as well as two INAD phased review user fee goals) reflects CVM's effort toward achieving statutory timeframes.

 

 
Review Time
Actual # of Days
FY 00 FY 01 FY 02 FY 03
Goal #1 - Original NADA's& reactivations of such applications
588
776
479
256
INAD phased review
Investigational animal drug study submissions with substantial data
498
625
993
328
Investigational animal drug submissions consisting of protocols without data
179
199
166
112
  • Final performance numbers for FY 2004 will not be available until later in FY 2005. However, as of September 30, 2004, ADUFA performance reflects 100% achievement of this goal. Additional information is available in the FY 2004 ADUFA Performance Report.
  • Data Sources: Submission Tracking and Reporting System (STARS).

2. Complete review and action on 90% of all new animal drug applications and supplements received in FY 03 within 275 days and complete review and action on 90% of all investigational new animal drug submissions received in FY 03 within 325 days. (14017)

  • Context of Goal: (This interim goal is dropped in FY 04 and replaced by Goal 1 which reflects a proposed user fee goal.) In FY 03, this performance goal reflects a new measure that is more useful for both Center management and industry. Key industry stakeholders have told us that 'how long an application takes to get reviewed' is more meaningful to them than 'what percent is reviewed on time'.

    When a new animal drug application is submitted, CVM evaluates the information contained or referenced in the application. A determination is made whether the application is approved or not approved. The sponsor receives a letter informing them either of the approval or describing the deficiencies in the application.

    The "days to review" refers to the time it takes to review and take an action on the original submission, or if needed, on subsequent recycles. This is different from total approval time which is the time it takes from the original receipt of the application until it is finally approved, which may take more than one review cycle. This includes the time we spend reviewing the application in each of the review cycles plus the time taken by the sponsor to respond to the issues raised in the not approved letter(s) and resubmit the application for review.

  • Performance: The performance reporting for FY 00 through FY 02 pertains to the review and action on NADA's and ANADA's within 180 days of receipt. CVM exceeded the FY 00 target with a performance rate of 84%.

    CVM found it necessary to shift focus in its performance regarding animal drug application review in FY 2000. The Office of New Animal Drug Evaluation (ONADE) needed to reduce the backlog of overdue submissions. This required working on the oldest, already overdue submissions. Decreasing the backlog was necessary in order to move CVM back on track towards meeting statutory and stakeholder requirements for new animal drug application review. By taking the step of closing out the most overdue submissions, CVM's on time completion rate for NADA's and ANADA's was adversely affected in FY 01 with 47% of NADA's and ANADA's reviewed on time.

    The goal for FY 02 was revised to complete review and action on 50% of NADA's/ANADA's within 180 days of receipt. The goal was revised from 80% to 50% because the Center has changed priorities and redirected resources to clear the large backlog of animal drug applications. In FY 02, the Animal Drugs and Feeds Program achieved 67% performance for this goal. The goal was revised in FY 03 to reflect a shift toward user fee performance measures. Based on the completed cohort timeframe, performance for the targets was exceeded on this goal for FY 2003: 99.3% of the NADA's and supplements reviewed and acted on within 275 days of receipt; and, 98.5% of INAD's reviewed and acted on within 325 days of receipt.

  • Data Sources: Submission Tracking and Reporting System (STARS).

3. Continue development, expansion and integration of the Staff College. (14018)

  • Context of Goal: Staff College programs have been developed as a means of continuously building the scientific and intellectual capability of FDA staff. The Staff College will increase and maintain a level of scientific expertise that is critical in order for CVM to address evolving animal science and veterinary medicine issues. The Staff College will outsource the planning and implementation of training programs tailored to the needs of in-house scientists. Performance for the goal has been met in FY 01, FY 02, FY03 and FY 04. The goal has transitioned from performance to maintenance due to stable performance; therefore, the goal has been dropped as of FY 05.
  • Performance:
  • FY 01: Initiated Phase I - conduct further needs assessment, feasibility studies, and analysis of alternatives:
    • Contract awarded to perform needs assessment and begin building the Staff College infrastructure necessary for a competency based learning management system to enhance the science-base.
    • Began the research and design of a training facility to support the infrastructure of the CVM Staff College. Awarded a facilities and equipment contract and construction of the training facility.
    • Recruited a FDA/CVM Search Team to conduct a nationwide search for a qualified Staff College Director who could continue building the Staff College infrastructure. Reviewed 130 candidates.
    • Conducted in-house development and implementation of seminars, professional meetings and courses that increased the science-based knowledge of the FDA's review staff which can help reduce review times and backlogs of pending applications.
  • FY 02: The goal to plan and design Phase I of the Staff College was completed:
    • Developed and implemented a CVM Competency Model through the automated Knowledge Center (KC). The KC is a Learning Management System (LMS) that has and will continue to help reduce administrative costs associated with managing and tracking training and development for the Center. This allows Staff College personnel to devote more time towards development of substantive programs that are responsive to the needs of the Center. The KC also creates and automates an Individual Development Plan (IDP) process for every employee to ensure that both the organizational and individual employee training and developmental needs are addressed.
    • Built state-of-the-art training facilities to accommodate distance learning initiatives as well as other traditional learning venues.
    • Continuing development of several in-house scientific/reviewer training programs.
  • FY 03 performance was achieved through development of several initiatives in the CVM Staff College Learning Management System (LMS) including:
    • Development of curriculum for animal drug reviewers and program evaluation requirements in order to measure course effectiveness;
    • Upgraded online Individual Development Plan (IDP) process;
    • Started work to attain provider status (accreditation) in order to offer continuing education credits; and,
    • Leveraged resources with the addition of CFSAN, CDER and OC to the Knowledge Center (KC).
  • FY 04 performance has been met:
    • Developed learning options using computer technology in order to support, enhance, and complement classroom based training.
    • The Staff College changed to a "semester system" permitting advanced announcement and access to course registration in the Knowledge Center.
    • The CVM New Employee Orientation (NEO) underwent enhancements that included easier access to registration, information, and the on-line portion of the Orientation in the Knowledge Center. The online enhancements included the addition of a "New Employee Orientation Checklist", "New Employee Benefits", "Mandatory Agency Training" and "A Tour of FDA'. An overview of "Basic Records Documentation" and the "High Performance Organization was also added to Part I of the NEO. All presentations given during Part 1 of the NEO were assessed and streamlined to include only the most important information needed by a new employee.
  • A "Certificate of Completion" was designed and can now be generated through the Knowledge Center once an employee has completed a CVM course.
  • Due to the upcoming implementation of the "HHS Learning Portal", focused on customized changes and enhancements to the CVM Knowledge Center which provide CVM employees with the latest scientific, technical and veterinarian specific information, courses, and learning options.
  • Courses have expanded significantly (since FY 03) to include:
    • Statistics, Scientific, Reviewer Rounds, Emerging Technology, Regulatory Law, and Drug Manufacturing Series;
    • Feed Manufacturing, Document Management (which was also added to the New Employee Orientation), Project Management, Occupant Emergency Plan, Interviewing, and "Love 'Em or Lose 'Em" (senior management tools for motivating and retaining employees).
  • Course evaluation has been enhanced through the implementation of the Audience Response System (ARS).
  • Initiated discussions and planning for Master's of Science and Master's of Public Health programs (with ONADE and the University of Maryland).
  • Data Sources: CVM's priority project tracking system.

4. 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. (14005)

  • Context of Goal: NARMS is a major national surveillance effort in cooperation with FDA, CDC, and USDA. NARMS detects emerging antibiotic resistance among foodborne pathogens and the possible associated health hazards through systematic collection, analysis and interpretation of antimicrobial susceptibility surveillance data. NARMS is adding to our knowledge of drug susceptibility and is helping ensure the continued effectiveness of human and veterinary drugs.

    One of the NARMS program goals has always been to provide timely information on antibiotic resistance to physicians and veterinarians to allow them to make informed decisions on treatment options for their patients. For example, a multi-drug resistant variant of Salmonella Newport emerged in humans and animals and was detected in the NARMS data. The participating NARMS agencies alerted the human and veterinary medical communities to this emergence so that they were aware and could take appropriate actions in treating infections with this organism.

  • Performance: In CY 99 = collected 8,510 animal and 1,706 human isolates; CY 00 = collected 9,000 animal and 2,000 human isolates. CY 01 = collected 6,795 animal, 1,671 human and 433 retail meat isolates. Although, NARMS testing was expanded in CY 01 (retail meats sampling added), fewer veterinary isolates were available for study. Salmonella sampling was not a part of the 2001 USDA/APHIS National Animal Health Monitoring System (NAHMS) program; therefore, isolates were not received from that program for NARMS antimicrobial susceptibility testing in 2001. In CY 02 12,000 salmonella isolates were collected. In FY 03, the goal was revised to reflect how CVM will use NARMS data to communicate with the public on antibiotic resistance. Previously, the goal reflected dependence on factors beyond FDA's control such as the number of humans contracting a foodborne disease as well as the sampling issue mentioned above. In FY 03, CVM accomplished this goal through various activities including poster sessions and presentations of NARMS information at scientific forums (sponsored by the American Society of Microbiology, the American Veterinary Medical Association, the United States Department of Agriculture and the Centers for Disease Control and Prevention). Other means of communication included: a NARMS article in the FDA Veterinarian as well as an article on the Mexico project in Antimicrobial Agents and Chemotherapy; updated NARMS information on FDA's web site.; and, a Spanish translation of the NARMS program brochure. In addition, there was the publication of the Annual Report of NARMS animal, human and retail meat data. In FY 2004 the following activities were accomplished in support of this goal:
    • Completed the first annual NARMS retail meat report. This can be found on line at the CVM web site. This report provides data on the prevalence of antimicrobial resistant food borne pathogens and commensal bacterial among retail meat and poultry samples;
    • Conducted numerous presentations on NARMS at national and international scientific meetings; and
    • Completed total revision of FDA CVM NARMS web page with the addition of NARMS peer-reviewed publications and FDA Veterinarian articles.

    Since the Center determined the goal has transitioned from performance to maintenance due to stable performance, the goal is dropped as of FY 05.

  • Data Sources: National Antimicrobial Resistance Monitoring System.

 

CDRH's Performance Goals

Performance Goals Targets Actual Performance Reference
1. Complete Review and Decision on 80% of Expedited PMA's within 300 days./1 (15033) FY 06: 80%
FY 05: 70%
FY 04: NA
FY 03: NA
FY 06:
FY 05:
FY 04: NA
FY 03: NA

4

Outcome Goal

2. Complete Review and Action on 90% of Premarket Approval Application of an estimated 80 (PMA) first actions within 180 days. (15001) FY 06: NA
FY 05: NA
FY 04: 90%
FY 03: 90%
FY 02: 90%
FY 01: 90%
FY 00: 85%
FY 99: 65%
FY 06:
FY 05:
FY 04: 6/06
FY 03: 97.7% of 43
FY 02: 97% of 33
FY 01: 97% of 70
FY 00: 96% of 67
FY 99: 74% of 43

4

 

3. Complete Review and Decision on 80% of 180 day PMA supplements within 180 days./1

(15031)

FY 2003 Review time 180 days

FY 06: 80%
FY 05: 80%
FY 04: NA
FY 03: NA
FY 06:
FY 05:
FY 04: NA
FY 03: NA

4

Outcome Goal

4. Complete Review and Action on 95% of an estimated 725 PMA supplement final actions within 180 days. (15009) FY 06: NA
FY 05: NA
FY 04: 95%
FY 03: 95%
FY 02: 90%
FY 01 90%
FY 00: 85%
FY 06:
FY 05:
FY 04: 6/06
FY 03: 95.5% of 157
FY 02: 95% of 498
FY 01: 98.4% of 641
FY 00: 98.7% of 545
4

5. Complete Review and Decision on 75% of 510(k)s (Premarket Notifications) within 90 days./1

(15032)

FY 06: 75%
FY 05: 75%
FY 04: NA
FY 03: NA
FY 06:
FY 05:
FY 04: NA
FY 03: NA

4

Outcome Goal

6. Complete Review and Action on 95% of an estimated 4,325 510(k) (Premarket Notification) final actions within 90 days. (15002) FY 06: NA
FY 05: NA
FY 04: 95%
FY 03: 95%
FY 02: 95%
FY 01: 95%
FY 00: NA
FY 06:
FY 05:
FY 04: 6/06
FY 03: 99% of 4328
FY 02: 100% of 4322
FY 01: 100% of 4248
FY 00: 100% of 4202
4
7. Complete 95% of PMA "Determination" meetings within 30 days. (15024) FY 06: NA
FY 05: NA
FY 04: 95%
FY 03: 95%
FY 02: 95%
FY 01: 95%
FY 00: 95%
FY 06:
FY 05:
FY 04: 100% of 2
FY 03: 100% of 1
FY 02: 100% of 1
FY 01: 100% of 3
FY 00: 100% of 3
4
8. Maintain inspection and product testing coverage of Radiological Health industry at 10% of an estimated 2000 electronic products. (15027) FY 06: 10%
FY 05: 10%
FY 04: 10%
FY 03: 10%
FY 02: NA
FY 01: NA
FY 06:
FY 05:
FY 04: 10% of 2,400
FY 03: 14% of 2000
FY 02: 5% of 2,000
FY 01: 10% of 2,000
FY 00: 10% of 2,000
4
9. Ensure at least 97% of an estimated 9,100 domestic mammography facilities meet inspection standards, with less than 3% with Level I (serious) problems. (15007) FY 06: 97%
FY 05: 97%
FY 04: 97%
FY 03: 97%
FY 02: 97%
FY 01: 97%
FY 00: 97%
FY 99: 97%
FY 06:
FY 05:
FY 04: 97% of 9,100
FY 03: 97% of 9,200
FY 02: 97% of 9,008
FY 01: 97% of 9,262; but with 3.4% with Level I (serious) problems.
FY 00: 97% of 9,443
FY 99: 97% of 9,583

4

Outcome Goal

10. Expand implementation of MedSun to a network of 350 facilities. (15012)

FY 06: Maintain a cohort of 350. Roll-out non-performers and replace with new sites to maintain the 350.

FY 05: Expand MedSun hospital network to 350 facilities.

FY 04: Build a MedSun hospital network of 240 facilities.

FY 03: Build a MedSun hospital network of 180 facilities.

FY 02: Implement MedSun by recruiting a total of 80 facilities for the network.

FY 01: Recruit a total of 75 hospitals to report adverse medical device events.

FY 00: Develop MedSun based on approximately 25 user facilities.

FY 99: Implement pilot

FY 06:

FY 05:

FY 04: FDA recruited, trained and has functioning 299 facilities for the network.

FY 03: FDA recruited, trained and has functioning 206 facilities for the network.

FY 02: FDA recruited, trained and has functioning 80 facilities for the network.

FY 01: FDA began feasibility testing with 25 hospitals and worked on software changes needed for web site. health data security.

FY 00: Developed MedSun Phase II Pilot based on approximately 25 user facilities.

FY 99: Pilot completed

 5

Outcome Goal

    # = corresponds to the relevant strategic goal in the HHS Strategic Plan

/1 DECISION GOALS applied to MDUFDA will be based on baseline data collected in FY 2003 and FY 2004.Decision goals identify the number of days for FDA to perform a complete review and issue a decision letter. Decision letters include: approval, approvable, approvable pending GMP inspection, not approvable and denial.
PMA first actions include: approval, approvable, approvable pending GMP inspection, not approvable, denial or "major deficiency letter.
PMA Supplement final actions include: approval, approvable, approvable pending GMP inspection, not approvable, or denial.
510(k) first actions include: SE, NSE, or "additional information" letter.

1. Complete Review and Decision on 80% of Expedited PMA's within 300 days. (15033)

  •  Context of Goal: Complete review and action constitutes the comprehensive review of the application package initially received by FDA and FDA's response back to the device sponsor.PMAs involve potentially high-risk devices with the most chance of significantly improving the treatment of patients. The steps taken in MDUFMA that will reduce approval times for applications are expected to reduce approval times for all ultimately filed applications, while recognizing that many applications may not ultimately meet FDA's standards for safety and effectiveness and that performance measures based on all applications will take more time to observe. The FDA will achieve this goal by reducing unnecessary cycles, through encouraging and supporting higher-quality applications and more efficient resolution of outstanding issues. For example, MDUFMA encourages more pre-submission meetings, especially for expedited products. FDA will use these interactions with sponsors to clarify requirements and improve the quality of applications so that there are fewer cases where FDA needs to stop the review clock and go back to sponsors to ask for more information. FDA is also using a collaborative process by leveraging with outside experts. The MDUFMA legislation includes a required statutory minimum amount of appropriated funds that must be provided each year for FDA's medical device and radiological programs.
  • Performance: The current baseline FDA marketing approval time for standard PMA's is 320 days. The approval of some key PMA's has been delayed, for example in the cardiac area, because CDRH doesn't have sufficient staff to handle simultaneous reviews that required the same review expertise. MDUFMA resources will be used both for new hires and to expand external expertise.
  • Data Sources: Center for Devices and Radiological Health (CDRH) Premarket Tracking System and Receipt Cohorts.

2. Complete Review and Action on 90% of Premarket Approval Application of an estimated 80 (PMA) first actions within 180 days. (15001)

  • Context of Goal: Complete review and action constitutes the comprehensive review of the application package initially received by FDA and FDA's response back to the device sponsor. PMA's involve potentially high-risk devices with most chance of significantly improving the treatment of patients. It is essential that FDA complete the review process for these products quickly and thoroughly. FDA anticipates significant complexity of PMA's For example, many new devices will incorporate computer technology as part of the diagnostic capability of the device itself and continuing improvements in image technology will require more sophisticated review skills. In addition, 40 percent of PMA are breakthrough technologies and approximately 35 percent are from first-time submitters. These factors add time to the normal review process. For FY 2005 this goal will be dropped and replaced with goal 15033.
  • Performance: This goal is currently on target to be completed successfully in FY 2004. The final FY 2004 data for this cohort will be available in 2006.The medical device program attained this goal in FY 2003 by completing review and action on 97.7% of PMA first actions within 180 days. CDRH expects to meet the target for this goal, as the preliminary data for this goal is 90% of 35. In FY 2001, FDA performance was 97 percent for the applications received in FY 2001. The performance strategy has been to redirect resources from low-risk to high-risk devices. However, in FY 2002, the Center's direct review effort was reduced by 20 FTE and the projected performance goal for FY 2003 has been reduced from 95 percent to 90 percent. FY 2004 was projected based on being able to maintain the FY 2003 performance. FY 2004 was projected based on being able to maintain the FY 2003 performance of completing review and action on 90% of premarket approval applications within 180 days.
  • Data Sources: Center for Devices and Radiological Health (CDRH) Premarket Tracking System and Receipt Cohorts.

3. Complete Review and Decision on 80% of 180 day PMA supplements within 180 days. (15031)

Note: Workload is anticipated to increase in FY 2004 due to advances in technology.
  • Context of Goal: Complete review and decision constitutes the comprehensive review of the application package initially received by FDA and FDA's decision letter. PMA's involve potentially high-risk devices that have the highest likelihood of significantly improving the treatment of patients. Supplemental applications are generally submitted for changes in already approved products such as technology changes or the addition of a new indication. It is essential that FDA complete the review process for these products quickly and thoroughly. Real-time PMA Supplement review is a regulatory tool that gives sponsors the option of participating in "real-time" reviews of certain device changes and these are conducted by teleconference or face-to-face. This gives manufacturers a chance to discuss all of FDA's review issues at one time. The MDUFMA legislation includes a required statutory minimum amount of appropriated funds that must be provided each year for FDA's medical device and radiological programs.
  • Data Sources: Center for Devices and Radiological Health (CDRH) Premarket Tracking System will develop during FY 2003 and FY 2004 baseline metrics for use in measuring FY 2005 PMA Supplement performance.

4. Complete Review and Action on 95% of an estimated 725 PMA supplement final actions within 180 days. (15009).

  • Context of Goal: Complete review and action constitutes the comprehensive review of the application package initially received by FDA and FDA's response back to the product sponsor. PMA supplements involve potentially high-risk devices that have the highest likelihood of significantly improving the treatment of patients. Supplemental applications are generally submitted for changes in already approved products such as technology changes or the addition of a new indication. It is essential that FDA complete the review process for these products quickly and thoroughly. Real-time PMA Supplement review is a regulatory tool that gives sponsors the option of participating in "real-time" reviews that are conducted by teleconference or face-to-face. This gives manufacturers a chance to discuss all of FDA's review issues at one time. In FY 2001, sponsors of over 25 percent of the 641 PMA supplements could use the real-time review option, mostly by teleconference. For FY 2005 this goal will be dropped and replaced with goal 15031.
  • Performance: This goal is currently on target to be completed successfully in FY 2004. The final FY 2004 data for this cohort will be available in 2006. CDRH met the target for this goal, completing review and action on 97% for the applications received in FY 2003. FY 2002 performance was 95 percent for the applications received in FY 2002.
  • Data Sources: CDRH Premarket Tracking System and Receipt Cohorts.

5. Complete Review and Decision on 75% of 510(k)s (Premarket Notifications) within 90 days. (15032)

  • Context of Goal: Complete review and decision constitutes the complete review of the application package initially received by FDA and FDA's response back to the product sponsor. This goal for review and decision on 510(k)s within 90 days addresses the statutory requirement to review a 510(k) within 90 days. The MDUFMA legislation includes a required statutory minimum amount of appropriated funds that must be provided each year for FDA's medical device and radiological programs. Without that minimum level or appropriation, the authority for FDA to collect and spend these medical device user fees will disappear on October 1, 2005-or in any subsequent year when appropriations fail to meet this minimum standard.
  • Performance: This goal is new for FY 2005
  • Data Sources: CDRH Premarket Tracking System and Receipt Cohorts.

    Third Party 510(k) Reviews are consistent with FDAMA's and MDUFMA's intent to encourage use of outside scientific and technical expertise, and provide an alternative to FDA review. 510(k)s reviewed by Accredited Persons received FDA marketing clearance 29 percent faster than comparable 510(k)s reviewed entirely by FDA. Additionally most Accredited Persons have specialized expertise in areas that may be helpful to 510(k) submitters, such as device testing, standards, or foreign regulatory requirements.

    In an effort to encourage greater use of the Third Party Program, FDA implemented an expansion pilot in 2001. FDA's experience and past progress can be found on the CDRH web site. located at http://www.fda.gov/cdrh/thirdparty/.

    Special and Abbreviated 510(k) Submissions provide manufacturers with reengineered submission procedures established by CDRH's New 510(k) Paradigm. These submissions are simpler to process than traditional 510(k)s, allowing more rapid market clearance. Past experience indicates that these types of submissions are rapidly increasing in numbers.

6. Complete Review and Action on 95% of an estimated 4,325 510(k) (Premarket Notification) final actions within 90 days. (15002)

  • Context of Goal: Complete review and action constitutes the comprehensive review of the application package initially received by FDA and FDA's response back to the product sponsor. This is an FY 1999 goal, dropped in FY 2000, and picked back up for FY 2001,

    FY 2002, FY 2003 and FY 2004 as a more meaningful measure of performance in this area. This goal for final actions on 510(k)s within 90 days addresses the statutory requirement to review a 510(k) within 90 days. Pressures to improve review time will increase in FY 2005 to meet MDUFMA goals. As directed by OMB, this goal was dropped for FY 2005 in order to streamline FDA's Performance Plan.

  • Performance: This goal is currently on target to be completed successfully in FY 2004. The final FY 2004 data for this cohort will be available in 2006. In FY 2003, performance is 99%. FY 2002, performance is 100 percent. This performance has resulted, in part, from FDA utilizing innovative ways to improve review efficiency. The two efforts listed under the heading of "Third Party Reviews" below are illustrative of FDA device review improvements. FDA encourages firms to use these regulatory options.
  • Data Sources: CDRH Premarket Tracking System and Receipt Cohorts.

    Third Party 510(k) Reviews are consistent with FDAMA's intent to encourage use of outside scientific and technical expertise, and provide an alternative to FDA review. During FY 2002, FDA received 127 510(k)s reviewed by third parties, a 19% increase from

    FY 2001. 510(k)s reviewed by Accredited Persons received FDA marketing clearance 29 percent faster than comparable 510(k)s reviewed entirely by FDA. An added bonus is that most Accredited Persons have specialized expertise in areas that may be helpful to 510(k) submitters, such as device testing, standards, or foreign regulatory requirements.

    In an effort to encourage greater use of the Third Party Program, FDA implemented an expansion pilot in 2001 that allowed Accredited Persons to review many Class II devices that were not previously eligible. The pilot allows, subject to certain conditions, Accredited Persons to review Class II devices for which there are no device-specific guidance documents. FDA's web site. is at http://www.fda.gov/cdrh/thirdparty/.

    Special and Abbreviated 510(k) Submissions provide manufacturers with reengineered submission procedures established by CDRH's New 510(k) Paradigm. These submissions are simpler to process than traditional 510(k)s, allowing more rapid market clearance. In FY 2002, the Agency received 787 Special 510(k) applications and 185 Abbreviated (510(k)s. 776 Special 510(k)s were processed within 28 days and all of the Abbreviated 510(k)s were acted on within the required 90 days, FDA expects to receive an estimated 1000 Special and Abbreviated 510(k) submissions in 2003.

7. Complete 95% of Premarket Approval Application (PMA) "Determination" meetings within 30 days. (15024)

  • Context of Goal: This performance goal deals with FDAMA requirements for increased interactions with sponsors and covers PMA Determination Meetings. A PMA Determination Meeting may be requested by a prospective PMA applicant to determine the type of scientific evidence necessary for PMA approval. FDA will continue to work to meet statutory review times and increase interactions with the medical device industry. FDA anticipates the use of premarket approval meetings will reduce the premarket review times and result in moving new products to the market faster. As directed by OMB, this goal was dropped for FY 2005 in order to streamline FDA's Performance Plan.
  • Performance: FY 2004 was 100 percent. FY 2003 performance was 100 percent. FY 2002 performance was 100 percent.
  • Data Sources: CDRH Premarket Tracking System and Receipt Cohorts.

8. Maintain inspection coverage and product testing coverage of the Radiological Health industry at 10 percent of an estimated 2,000 electronic products. (15027)

  • Context of Goal: FDA is seeing a resurgence of problems in both the medical and consumer radiological product area such as widespread new uses for fluoroscopy by relatively untrained practitioners increasing the risk of over exposure and high emission rates from consumer products. FDA has monitored cases of unnecessary radiation emitted during fluoroscopy. Principal risks to patients from over-exposure include long-term possibilities for cancer induction and a short term potential for skin burns. FDA is proposing new regulations that would require more restrictive specifications for new equipment. FDA estimates the new regulations can spare 723 lives per year from radiation-induced cancer, recognizing it averages 30 years for the long-term radiation-induced cancer to emerge after exposure. FDA has also established a working collaborative with the ACC, (cardiologists being a most frequent user) to educate other users. FDA also receives approximately 5,000 electronic product reports yearly. Since FDA can't review these on a one-by-one basis, FDA plans to select product areas that require immediate attention by testing specific automatic screening criteria for electronic reports.
  • Performance:FDA met this goal by inspecting 10% of 2,400; 14% of 10,400 Dx X-Ray units installed based on m204 data; 80% of planned Dx XRay; WEAC sample analysis based on PODS data. Accomplishment varies by industry for non-medical electronic products, averaging 10% overall. FDA met this goal by inspecting 14% of active radiological health firms. In FY 2003, FDA estimates there were approximately 2,000 active radiological health firms FDA is responsible for regulating domestically and internationally. In FY 2002, CDRH was able to check the compliance status for about 5 percent of these firms, by reviewing inspection reports and product testing reports submitted by manufacturers. FDA initiated activities to prioritize and leverage its radiation protection efforts with state governments, professional societies, and other federal agencies. This compliance status was estimated by CDRH's Office of Compliance by reviewing inspection reports from FDA and State inspectors and product testing reports submitted by industry.
  • Data sources: CDRH Radiological Health Data Systems.

9. Ensure at least 97% of an estimated 9,100 domestic mammography facilities meet inspection standards, with less than 3% with Level I (serious) problems. (15007)

  • Context of Goal: This goal will ensure that mammography facilities remain in compliance with established quality standards and improve the quality of mammography in the United States. In the Mammography Quality Standards Reauthorization Act (MQSRA) of October 1998, Congress authorized the FDA to undertake a demonstration program to assess the results of conducting mammography inspections less frequently than annually for the highest performing facilities. The program was implemented in May 2002. MQSA expired on September 30, 2002, but FDA expects MQSA to be reauthorized during the 2004 congressional session. Under MQSA, trained inspectors with FDA, with State agencies under contract to the FDA, and with States that are certifying agencies, performed annual MQSA inspections. State inspectors do approximately 90 percent of inspections. Inspectors performed science-based inspections to determine the radiation dose, to assess phantom image quality, and to empirically evaluate the quality of the facility's film processing. MQSA requires FDA to collect fees from facilities to cover the cost of their annual facility inspections. FDA also employs an extensive outreach program to inform mammography facilities and the public about MQSA requirements. These include: an Internet web site., collaboration with NIH to provide a list of MQSA-certified facilities, and a toll fee facility hot line.
  • Performance: FDA met this goal in FY 2004 by ensuring that 97 percent of an estimated 9,100 mammography facilities met inspection standards with less than 3 percent level 1 (serious) problems. During FY 2003, FDA ensured that 97 percent of mammography facilities met inspection standards and with less than 3 percent with Level 1 (serious) problems. Inspection data continue to show facilities' compliance with the national standards for the quality of mammographic images. Improving the quality of images should lead to more accurate interpretation by physicians and, therefore, to improved early detection of breast cancer. FDA works cooperatively with the States to achieve this goal.
  • Data Sources: Mammography Program Reporting and Information System (MPRIS)

10. Expand implementation of the MedSun System to a network of Expand implementation of MedSun to a network of 350 facilities. (15012)

  • Context of Goal: FDAMA gives FDA the mandate to replace universal user facility reporting with the Medical Product Surveillance Network (MedSun) that is composed of a network of user facilities that constitute a representative profile of user reports. FDA estimates that there may be as many as 300,000 injuries and deaths annually associated with device use and misuse. FDA has developed a long-term goal to increase the percent of the population covered by active surveillance, which will allow for more rapid identification and analysis of adverse events. FDA's long-term goal is: "Increase by 50% the patient population covered by active surveillance of medical product safety by 2008". MedSun is a critical component towards achieving this long-term goal. When fully implemented, MedSun will reduce device-related medical errors; serve as an advanced warning system; and create a two-way communication channel between FDA and the user-facility community. MedSun is designed to train hospital personnel to accurately identify and report injuries and deaths associated with medical products. Data collection began in March 2002 and continues to date, along with recruitment of participating centers. FDA's goal for FY 2003 was to recruit at least 180 facilities. For 2004, with increased funding, FDA exceeded its goal of recruiting 240 facilities. Instead, it recruited 299 facilities. In FY 2005, FDA will recruit new facilities to expand the network to 350, and to replace those facilities that choose to leave. The goal for FY 2006 will be to maintain a cohort of 350 sites, replacing sites that wish to leave the program or have not been active participants. The enhancement of the adverse events data system and linkages with other health care systems is the first line of defense against medical errors, supporting the Department's initiative to improve the quality of health care services. In 2004, the agency expanded the MedSun model to include a pilot study to evaluate procedures for collecting data on problems with laboratory tests and to evaluate the feasibility of including hospital laboratory staff. The laboratory staff from five (5) facilities were utilized. The information received about laboratory devices was very useful to FDA, so it has been decided to expand the laboratory data collection to the remaining MedSun sites. Additionally, FDA plans to use the cohort of 350 facilities to pilot the effectiveness of various incentives, to pilot use of the MedSun facilities as a laboratory to obtain specific medical product information, and to pilot various types of feedback intended to encourage reporting by the facilities. FDA will continue to research and develop improved feedback mechanisms to the participating facilities about problems with medical devices The agency will implement targeted surveillance of different parts of hospitals (ex. ICU, Operating Room, etc.), and of particular devices; and will also continue to explore how to improve reporting from hospital laboratories (LabSun), develop educational materials to raise awareness about the need to report device problems within institutions and to FDA, and continue the successful audio conferences which discuss items of interest to biomedical engineers.
  • Performance: In FY 2004, FDA exceeded its MedSun recruitment goal by recruiting a total of 299 facilities.In FY 2003, the agency met its goal by recruiting a total of 206 facilities into the MedSun system. In FY 2002, FDA recruited, trained and had functioning 80 facilities for the network. In FY 2001, FDA did not meet the goal of recruiting 75 hospitals because most of the effort was focused on resolving internal policy issues and addressing information technology security requirements. During FY 2002, FDA extended software development to accommodate Internet-based reporting system (interactive web-based form and database), and took steps to ensure that reporters had Internet access to secure servers.
  • Data Sources: CDRH Adverse Events Reports.

National Center for Toxicological Research Performance Goals

Performance Goals Targets Actual Performance Reference
1. 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. (16014)

FY 06: Present one finding utilizing novel technologies to assess changes in genes and pathology, and the relationship between chemical exposure, toxicity and disease.

FY 05: Develop at least one protocol (proof of concept) to aid in defining drug toxicity studies and studies into mechanistic age-associated degenerative disease.

FY 04: Use toxicoinformatics, combining information technology with toxicity data, to assess human risk for one regulated product (proof of concept)

FY 06:

FY 05:

FY 04:Used biologically-based models of cancer-causing mutations to study skin tumor induction by regulated physical and chemical products.

4
2. Develop computer-based models and infrastructure to predict the health risk of biologically active products. (16003)

FY 06: Interpret at least one toxicology study at the molecular level utilizing the DNA microarray database (ArrayTrack).

FY 05: Develop a computer-based system to integrate databases, libraries and analytical tools to support risk analysis and assessment.

FY 04: Expand current technologies to include risk assessment for two biologically active products of interest to the FDA.

FY 03: Maintain existing computational databases of estrogenic and androgenic compounds for use by reviewers.

FY 02: Maintain existing computational databases of estrogenic and androgenic compounds for use by reviewers.

FY 01: Validate a predictive model for androgens.

FY 00: Validate predictive model for estrogenic or estrogenic-like compounds.

FY 99: Demonstrate a model toxicity knowledge base to support and expedite product review

FY 06:

FY 05:

FY 04:Modeled in vivo gene mutation and genotoxicity data to gain insight into the mechanism of action and relative risk posed by liver and lung carcinogens.

FY 03: The data is available for public access and allows for integration of information across health research fields.

FY 02: Developed an integrated Toxicoinformatic System that includes a central data archive, mirrored public databases, and analysis functions.

FY 01: Predictive model for androgen receptors was developed and assessment of 204 chemicals completed.

FY 00: The estrogenicity of 150 chemicals was assessed using an estradiol receptor-binding assay validating the predictive model. Two additional assays were evaluated for androgen binding.

FY 99: Thirty (30) chemicals for CFSAN and six chemicals for CDER have been used to confirm the predictive value of the computer modeling system.

Partnering continues with other agencies (EPA, etc.) and industry (CMA).

4
3. Develop risk assessment methods and build biological dose-response models in support of Food Security. (16007)

FY 06: Demonstrate one utility of an oligonucleotide-microarray method as an integrated strategy to respond to antibiotic resistant agents in foodborne pathogens and bioterror agents.

FY 05: Develop molecular method (oligo-microarray) to detect and monitor foodborne pathogenic bacteria.

FY 04: Under the Food Safety Initiative, establish a nutrition program in collaboration with other centers to address the risk associated with obesity in children, nutrition in pregnant women and poor nutrition in sub-populations; and initiate analysis on samples requiring high levels of containment in an accredited biosafety level 3 (BL-3) facility

FY 03: Identify and characterize the role antibiotic resistance plays in emerging and evolving foodborne diseases.

FY 02: Report at scientific meetings and/or publish preliminary results on the development of new methodologies to identify genetically modified foods, drug residues in foods and antibiotic-resistant strains of bacteria.

FY 01: Provide model to replicate bacterial survival in the stomach.

FY 00: Develop methods of predicting, more quickly and accurately, the risk associated with such foodborne pathogens as Salmonella spp., Shigella spp., and Campylobacter spp.

FY 99: Develop rapid and sensitive methods for identifying pathogens, foodborne bacteria, and microbial contaminants

FY 06:

FY 05:

FY 04:Collaborative efforts that support this goal / target include participation on a committee involving CFSAN, CVM, and NCTR. This committee has prepared a white paper entitled, "Filling Critical FDA-Related Food and Nutrition Research Gaps." Analyzed surrogate microbes to test methodology as well as the public health risk for foodborne hazards.

FY 03: Studies are being conducted to determine whether antimicrobial resistance occurs in bacteria isolated from animal feeds containing antibiotics and to identify the pattern of resistance.

FY 02: Researchers published approximately 50 publications and made approximately 20 presentations relating to food safety.

FY 01: Performed pre-validation studies that examine the effect of low-level antibiotic residues on the human intestinal microflora by using a chemostat to model the human intestinal tract.

FY 00: Studies are continuing on the in vitro model and molecular analysis of competitive exclusion pro-ducts; molecular screening methods have been developed for the determination of vancomycin and fluoroquin-olone resistance in Campylo-bacter sp. isolated from poultry.

FY 99: A project to detect simultaneously 13 species of foodborne pathogens in a single food sample was completed and is undergoing validation.

CVM has been alerted to the danger associated with using antibiotic-resistant bacteria for competitive exclusion product in the poultry industry.

2
4. Catalogue biomarkers and develop standards to establish risk in a bioterrorism environment. (16012)

FY 06: Present one finding utilizing neuropathology and behavioral risk evaluation in the prediction of human outcome to food-borne toxicants.

FY 05: Present one finding using neural imaging to identify neurotoxicity in exposed populations.

FY 04: Apply neural imaging to identify and quantify neurotoxicity in exposed populations; and upgrade NCTR's animal quarantine facility to conduct animal research requiring BL3 containment in order to evaluate the effect of bioterrorism agents contaminating the food supply.

FY 03: Develop one instrumental rapid sensor detection method.

Outfit upgraded laboratory, provide for supplies (agents, chemicals/pathogens) and construct library databases of proteins and test to find toxin related markers;

Recruit additional expertise in Computational Science, Chemistry and Microbiology.

FY 02: Continue development of solid-phase colorimetric bacterial detection system. Acquire high-resolution mass spectrometer for use with protein from bacteria, food toxins and genomics studies.

Upgrade existing laboratory facilities to BSL-3 to support BSE/TSE and microbial bioterrorism work. Recruit additional expertise in Computational Science, Chemistry and Microbiology.

FY 01: Begin developing solid-phase colorimetric bacterial detection system.

FY 00: Begin developing solid-phase colorimetric bacterial detection system.

FY 06:

FY 05:

FY 04:A proposal was generated that is designed to determine the reversibility of the development of the effects of the dissociative anesthetic, ketamine, with the use of MicroPET imaging techniques. A portion of the quarantine facility has been "up graded" to conduct animal BSL3) cryptosporidia studies.

FY 03: The Pyrolysis MAB MS computational system was installed and generating data that shows a very rapid characterization of potential bioterror bacterial strains is possible. Staff was recruited and the BSL-3 laboratory will be ready for use by mid 2004.

FY 02: Scientists are working on streamlining this methodology for use on meat as well as seafood. Equipment was purchased and calibrated.

An outside firm assessed the NCTR facility for laboratory architecture and requirements; and, a floor plan was developed. One computational scientist, three chemists and two microbiologists were hired.

FY 01: Application/extension of Fresh Tag® technologies for detection of nitrogen-based explosives began.

FY 00: Goal not meet due to lack of funding

2
    # = corresponds to the relevant strategic goal in the HHS Strategic Plan

1. 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. (16014)

  • Context of Goal: Staying abreast of new technologies in science is important for the Agency to protect public health. This goal is designed to establish core competencies within the FDA that can form a foundation for future high technology science. Techniques developed under this goal will utilize the emerging knowledge of the human genome and rapid biological analyses to improve human health, and to insure the safety of marketed products.
  • Performance: NCTR developed a unique and sophisticated analytical infrastructure to assess the safety of FDA-regulated products using genomics, proteomics and metabolomics in conjunction with traditional biomarkers of safety. The development of this research approach is directed toward creation of a more relevant and quantitative risk assessment paradigm. A systems biology approach to toxicity testing will provide data that will be more easily extrapolated to the human making data interpretation more facile and relevant.The result will be new disease markers and drug targets that aid in design of products to prevent, diagnose and treat disease. Researchers have combined mechanistic information with toxicity data to perform a mechanistically based cancer assessment on fumonisin B1 that provided support and justification for FDA's guidance levels for fumonisins in corn products. Scientists are actively pursuing collaborations in the systems biology realm of research with industry, academia, and within FDA.
  • Data Sources: NCTR Project Management System; peer-review through FDA/NCTR Science Advisory Board and the NTP Scientific Board of Counselors; presentations at national and international scientific meetings; and manuscripts prepared for publication in peer-reviewed journals.

2. Develop computer-based models and infrastructure to predict the health risk of biologically active products. (16003)

  • Context of Goal: Using a scientifically based endocrine disruptor knowledge base (EDKB), FDA-regulated drugs, food additives, and food packaging have been shown to contain estrogenic activity. This raised the level of concern regarding adverse effects on human development/reproduction and contributions of these compounds to high incidences of cancer and/or risk of other diseases. Following the success achieved with the EDKB, NCTR scientists will identify and predict, using knowledge bases, whether the increased exposure to naturally occurring and other synthetic products can adversely impact public health.
  • Performance: The development of the knowledge base for assessing risk associated with other regulated products continues. NCTR developed an integrated Toxicoinformatic System that includes a central data archive, mirrored public databases, and analysis functions. The central data archives contain a set of relations databases, each storing experiment information. These databases are continually being updated, enhanced with new linkages and additional experimental data and are being used to assess compounds for NCTR, CFSAN, CDER and EPA. In FY 2004, scientists used biologically based models of skin tumor development that use oncogene and tumor suppressor gene mutation frequency to describe skin tumor development. Comparisons will be made between spontaneous tumor induction, after treatment with simulated solar light (as would be encountered in a tanning salon), and after simulated solar light in combination with various cosmetic products. Modeling also was performed with a number of model toxicants, including riddelline, a food contaminant that is a liver carcinogen and 1,6-dinitropyrene, a combustion product that is a lung carcinogen.
  • Data Sources: Use of the predictive and knowledge-based systems by the FDA reviewers and other government regulators; NCTR Project Management System; peer-review through the FDA/NCTR Science Advisory Board; presentations at national and international meetings.

3. Develop risk assessment methods and build biological dose-response models in support of Food Security. (16007)

  • Context of Goal: The Agency is mandated by law to assure that the American public is eating safe food. Therefore, the Agency must strengthen its scientific basis for food security policies and regulatory decisions through the development of novel, vigorous risk assessments (models and techniques) and through the use of artificial intelligence and computational science for risk assessments. Concurrently, the Agency must accelerate the identification and characterization of mechanisms and methods development/ implementation to support surveillance and risk assessment for imported foods and/or microbial contamination.
  •  Performance: Researchers at the NCTR, the Center for Food Safety and Applied Nutrition (CFSAN), and the Center for Veterinary Medicine (CVM) are continuing to perform studies on bacterial identification techniques both in the food supply and in microbial contamination. This research includes the elucidation of the mechanisms of resistance to antimicrobial agents among bacteria from poultry and vegetables. Microbiological experiments have been conducted that suggest a technique to reduce or eliminate contamination of the environment in agricultural uses of clinically important antibiotic drugs. The pattern of resistance development in bacteria found in animals fed antibiotic and differences in survival rates of drug-resistant pathogens compared to non-resistant pathogens will continue to be studied. In FY 2004 efforts included the evaluation of various molecular methods to detect and identify the foodborne pathogens Campylobacter and Salmonella species and Vibrio parahaemolyticus from various foods and environmental matrices.
  • Data Sources: NCTR Project Management System; peer-review through FDA/NCTR Science Advisory Board; presentations at national and international scientific meetings; and manuscripts prepared for publication in peer-reviewed journals.

4. Catalogue biomarkers and develop standards to establish risk in a bioterrorism environment. (16012)

  • Context of Goal: Identification of biomarkers is important because it will allow rapid identification of and response to potential contamination. These proteins identify specific genes that are potential targets for introduction of foodborne pathogenicity. The methodology as well as the biomarkers will be useful for rapid identification of hazards. Scientists will be able to expand a novel approach pioneered at the NCTR to rapidly identify biomarkers of toxicity associated with biological warfare agents. These types of agents used by bioterrorists would be difficult to detect using existing technology. This research is conducted in collaboration with the Centers for Disease Control (CDC), the Department of Defense (DoD), Naval Research Labs, the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) and the Center for Food Safety and Applied Nutrition (CFSAN). In FY 2004, the chemistry and microbiology programs compared novel mass spectrometric methods with cultural methods, serological tests and molecular genetic methods for rapid identification of foodborne pathogens. This method will reduce analysis time of contaminated food to a few hours which will protect public health in a suspected bioterrorist attack. NCTR has upgraded the Center's Biosafety Level-3 animal quarantine facility and early FY 2005 the Center will begin utilizing the laboratory to evaluate the effect of possible contamination agents.
  • Performance: Chemical sensor technology for the assessment of food quality was further developed and the concept evolved into both a commercial version and a consumer version. The research extended to detect other endpoints that are measures of product quality and freshness. As an extension of this work, an interagency agreement was established with the Federal Aviation Administration (FAA) to detect explosives in airline cargo. Studies are being conducted to compare and contrast several new mass spectrometry techniques to more rapidly evaluate microbial risk. In FY 2003, scientists shared expertise and laboratory infrastructure to prevent or minimize threats from bioterrorism through the development of a Memorandum of Agreement with the Arkansas Department of Health. Scientists also developed in collaboration with the Arkansas Regional Laboratory a method for microbial isolation that dramatically reduces analysis time of contaminated food to only a few hours vs. 2-3 days.
  •  Data Sources: NCTR Project Management System; peer-review through FDA/NCTR Science Advisory Board, the NTP Scientific Board of Counselors, and the Food Safety Initiative Coordinating Committee; presentations at national and international scientific meetings; and manuscripts prepared for publication in peer-reviewed journals.

 

ORA Performance Goals

Performance Goals Targets Actual Performance Appendix Reference
1. 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. (11040)

FY 06: 38,000 reviews

FY 05: 38,000 reviews

FY 04: NA

FY 06:

FY 05:

FY 04: 33,111

 2,4

 

2. Perform 60,000 import food field exams on products with suspect histories. (11036)

FY06: 60,000 exams

FY05: 60,000 exams

FY04: 60,000 exams

FY03: Increase exams by

100% to 48,000 exams.

FY02: Hire 300 new investigators and analysts to increase the number of import field exams by 97% to 24,000 exams.

FY 06:

FY05:

FY04: 70,926

FY03: 78,659 field examinations due to Operation Liberty Shield.

FY02: Hired 600 new investigators and analysts; 34,447 exams conducted.

FY01: 12,169

 2,4
 3. Perform at least 1,000 Filer Evaluations under new procedures. (19015)

FY 06: 1,000 Filer Evaluations.

FY 05: 1,000 Filer Evaluations.

FY 04: 1,000 Filer Evaluations

FY 06:

FY 05:

FY 04: 1,745

 2
4. 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. (19016)

FY 06: 2,000 examinations

FY 05: 2,000 examinations

FY 04: 2,000 examinations

FY 06:

FY 05:

FY 04: 4,905

2
5. Conduct postmarketing monitoring, food surveillance, inspection, and enforcement activities to reduce health risks associated with food, cosmetics and dietary supplements products. (11020)

Inspect 95% of estimated 6800 high-risk domestic food establishments once every year.

FY 06: 95%
FY 05: 95%
FY 04: 95%
FY 03: 95%
FY 02: 95%
FY 01: 90%

FY 06:
FY 05:
FY 04: 111% of 6,840
FY 03: 105% of 7000
FY 02: 97% of 7000
FY 01: 78% of 6800
FY 00: 91% of 6250

4

Supports Healthy People 2010 Objectives

 6. 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. (11027) FY 06: NA
FY 05: NA
FY 04: 8,000 +
FY 03: 8,000 +
FY 02: 8,000 +
FY 01: 8,000 +
FY 00: NA
FY 99: NA

FY 06:
FY 05:
FY 04: 12,682
FY 03: 11,331
FY 02: 10,700

FY 01: 8,250 total (7,600 pesticide residues including 1,100 TDS; 650 dioxin including 250 TDS)

FY 00: 7,400 total (2,500 domestic and 4,900 imported)

FY 99: 9,400 total pesticide and chemical contaminant samples: 3,400 domestic and 6,000 imports.

4

Supports Healthy People 2010 Objectives

 7. Expand federal/state/local involvement in FDA's eLEXNET system by having 105 laboratories submit data in the system. (19013) FY 06: 105 laboratories
FY 05: 95 laboratories
FY 04: Add 25 more laboratories for a total of 79
FY 03: 54 laboratories participating in eLEXNET
FY 06:
FY 05:
FY 04: 79 laboratories submitting data in eLEXNET
FY 03: 55 laboratories participating in eLEXNET
FY 02: 29 laboratories
FY 01: 14 laboratories

2

Outcome Goal

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

(12020)

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

FY06: Inspect 65% of the establishments identified as high-risk.

FY 05: 55% of an estimated 685 establishments in the high-risk category.

FY 04: 55% of an estimated 685 establishments in the high-risk category.

FY 03: 55% of an estimated 630 establishments in the high-risk category.

FY 06:
FY 05:
FY 04: 70% of 683
FY 03: 60% of 971
4
9. 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. (13012)

FY 06: 50% of approximately 2,600 establishments

FY 05: 50% of approximately 2,700 establishments

FY 04: 50% of approximately 2,700 establishments

FY 03: 50% of approximately 2,700 establishments

FY 02: 50%
FY 01: 50%
FY 00: 50%
FY 99: 50%

FY 06:
FY 05:
FY 04: 55% of 2,648
FY 03: 60% of 2,662
FY 02: 52% of 2,730
FY 01: 57% of 2,756
FY 00: 57% of 2,756
FY 99: 64% of 2,790
4

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

(14009)

1. Maintain biennial inspection coverage by inspecting 50% of all registered animal drug and feed establishments.

FY 06: 50% of 1,390
FY 05: 50% of 1,390
FY 04: 50%
FY 03: 50%
FY 02: 50%
FY 01: 50%
FY 00: 27%
FY99: 27%

2. Conduct targeted BSE inspections of 100% of all known renderers and feed mills processing products containing prohibited material.

FY 06: 100%
FY 05: 100%
FY 04: 100%
FY 03: 100%
FY 02: 100%

1. Maintain biennial inspection coverage by inspecting 50% of all registered animal drug and feed establishments.

FY 06:
FY 05:
FY 04: 55% of 1,416
FY 03: 58.8% of 1440
FY 02: 55% of 1460
FY 01: 37% of 1460
FY 00: 39% of 1460
FY 99: 25% of 1418

2. Conduct targeted BSE inspections of 100% of all known renderers and feed mills processing products containing prohibited material.

FY 06:
FY 05:
FY 04: 100% of 647
FY 03: 100% of 880
FY 02: 100% of 1,305

 4
11. Conduct 295 domestic and foreign BIMO inspections with an emphasis on scientific misconduct, data integrity, innovative products, and vulnerable populations. (15025) FY 06: 295
FY 05: 295
FY 04: 295
FY 03: 295
FY 02: 290
FY 01: 250
FY 06
FY 05:
FY 04: 354
FY 03: 364
FY 02: 358
FY 01: 238
FY 00: 249
 4
12. 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. (15005.01) FY 06: 20%
FY 05: 20%
FY 04: 20%
FY 03: 20%
FY 02: 20%
FY 01: 17%
FY 00: 22%
FY 99: 26%
FY 06:
FY 05:
FY 04: 25% of 5,576
FY 03: 26% of 5,400
FY 02: 20% of 5,326
FY 01: 20% of 4,980
FY 00: 13% of 5,462
FY 99: 30% of 2,930
 4
13. 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. (15005.02) FY 06: 7%
FY 05: 7%
FY 04: 9%
FY 03: 9%
FY 02: 9%
FY 01: 9%
FY 00: 9%
FY 99: NA
FY 06:
FY 05:
FY 04: 12% of 2,500
FY 03: 9% of 2,500
FY 02: 8% of 2,550
FY 01: 11% of 2,418
FY 00: 11% of 2,370
FY 99: 10% of 2,080
 4
14. 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). (11041)

FY 06: Achieve and maintain accreditation for 13 laboratories

FY 05: Achieve and maintain accreditation for 6 laboratories

FY 04: NA

FY 06:
FY 05:
FY 04: 2 labs accredited

2

Outcome Goal

1. 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. (11040)

  • Context of Goal: FDA's Prior Notice Center 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 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. In FY 2006, 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. By FY 2006, FDA expects that the Prior Notice Center will have hired a permanent staff of Reviewers and Watch Commanders that will have achieved the training and gained the experience necessary to expand its scope of targeting to include additional threat parameters. The Prior Notice Center utilizes the import field exams and filer evaluations by receiving feedback from the Investigators who conduct them and targeting those individuals that continuously violate the prior notice regulations and the provisions set forth in the Bioterrorism Act. They also target commodities based on immediate and potential threats to the integrity and security of the intact food supply chain. In addition, broader surveillance of products imported from countries considered to be at a higher risk for terrorist activities can be incorporated into targeting goals. Strategies used to ensure effective targeting will include:
    • Intelligence regarding countries at risk for terrorism;
    • Intelligence regarding commodities susceptible to or exploited by terrorism;
    • Intelligence specific to shipment or shipping entities;
    • Information gleaned from Foreign and Domestic Establishment Inspection Reports that identify security breaches;
    • Sample collection and analysis for counterterrorism;
    • Prior Notice discrepancies reported during import field exams; and,
    • Filer evaluation field audits.

    FDA anticipates that the measures that it uses to assess its success in monitoring the safety and security of imported products will continuously evolve as trade practices and information about risks change.

  • Performance: This goal is new for FY 2005 since the Bioterrorism Act became effective in December of 2003. In FY 2004, FDA collaborated with Customs and Border Protection to direct field personnel to hold and examine 20 suspect shipments of imported food; responded to 20,430 inquiries; and conducted 33,111 intensive security reviews of Prior Notice submissions out of 6,294,821 in order to intercept contaminated products before they entered the food supply.

    The import security reviews that are performed by the Prior Notice Center are performed on those prior notice submissions that are selected after intelligence, known risk factors and information available about the shipper and consignee are applied to the prior notice submission data. The selection of candidates for security review is not related to the volume of submissions; they are selected on the basis of risk factors. If threats are reduced, then it is possible for the number of security reviews to decline. One possible circumstance might be the suspension of imports from a country or countries whose potential imports trigger many security reviews. Another possibility could be dramatically increased numbers of reviews because of newly identified risk factors. The 38,000 estimate of the number of security reviews to be performed is simply an estimate based on the recent past. In today's risky environment, it may be well over or under, the number that will be performed. It is the quality of the targeting information and the quality of the review itself that provides the security, not the proportion of potential items selected for security review.

  • Data Sources: Field Data Systems (OASIS and FACTS).

2. Perform 60,000 import food field exams on products with suspect histories. (19014)

  • Context of Goal: The events of September 11, 2001 heightened the nation's awareness of security and placed a renewed emphasis on ensuring the safety of the nation's food supply. Import food field exams, along with laboratory analyses, were FDA's major tool to physically monitor import entries prior to the enactment of the Bioterrorism Act of 2002.

    A field examination is a visual examination of the product to determine whether the product is in compliance with FDA requirements and involves actual physical examination of the product for admissibility factors such as storage or in transit damage, inadequate refrigeration, rodent or insect activity, lead in dinnerware, odor and label compliance. A field exam cannot be used to test for microbiological or chemical contamination and must be supplemented with other activities.

    The volume of imported food shipments has been rising steadily in recent years, and this trend is likely to continue. FDA-regulated imports have been growing at a 19% annual rate. FDA anticipates 10 million line entries of imported food in Fiscal Year 2006 within a total of 15 million lines of FDA regulated entries. To manage this ever-increasing volume, FDA uses risk management strategies to achieve the greatest food protection with limited resources. Given the continuing explosion in the number of import shipments to this country, FDA cannot keep pace with the increasing volume by simply expanding the number of import field examinations.

    FDA applies strategies that combine visual inspection for apparent labeling and other visual defects, with risk based targeting, and selective laboratory analysis to detect chemical and microbiological hazards. FDA cannot rely solely on physical examination to reduce the potential risks from imported foods. Currently, a significant effort is underway to develop appropriate knowledge-based approaches that will give the Agency assurance that it is addressing the most serious risks. 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 Bioterrorism Act of 2002 provided FDA with new authorities to protect the nation's food supply against the threat of intentional contamination and other food-related emergencies. These new authorities improve our ability to act quickly to respond to a threatened or actual terrorist attack, as well as other food-related emergencies. The implementation of Prior Notice review of imported foods has provided FDA with a new tool for assessing the risks of imported food and added a new tool to improve the focus of import food risk assessment. Prior Notice Import Security Reviews are the subject of a new FDA field performance goal. In response to the heightened concern over the safety of imported products, FDA continues to make fundamental changes in how it makes entry decisions on imported foods. These new Prior Notice Import Security Reviews are just one example of the expanded targeting and follow through on potentially high risk import entries that FDA is developing to complement the import field exam.

    Because of the need to staff the Prior Notice Center, and the larger than anticipated pay increase in FY 2005, ORA will not be able to increase import field food exams in FY 2005 or FY 2006. The FY 2005 budget will allow the FDA to fund only 2,078 Field Food FTE which is 51 fewer FTE's than expected. As a result, the increase in FY 2005 funding will not allow for the hiring of additional FTE and the proposed increase in field exams will not take place. Therefore, the targets have been reduced.

  • Performance: The FY 2002 performance was 600 new investigators and analysts hired and 34,447 import field exams conducted. This exceeded the FY 2002 target of 24,000 exams. In FY 2003, FDA completed 78,569 field examinations of imported food lines entering U.S. ports of entry for release into the U.S. commerce. The FY 2003 performance exceeded the 48,000 target because of activities supporting the Liberty Shield intensive review of imports. Regardless of the increase in exams, ORA continues to believe the best approach is to devote resources to better targeting and following through on suspect import entries rather than significantly expanding import coverage. In FY 2004, FDA completed 70,926 field examinations of imported food lines.
  • Data Sources: Field Data Systems.

 3.  Perform at least 1,000 Filer Evaluations under new procedures. (19015)

  • Context of Goal: 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 maintains an electronic interface with the Department of Homeland Security's Bureau of Customs and Border Protection (CBP), the Automated Commercial System (ACS). After successfully completing an initial evaluation for participation in OASIS, filers may submit import data electronically to FDA through the Automated Broker Interface (ABI) and ACS. FDA uses an electronic entry screening system, Operational and Administrative System for Import Support (OASIS), to screen entry data transmitted by filers to perform various regulatory and service functions. Such screening may assess whether FDA import personnel should review an entry further. The FDA uses OASIS to determine whether an entry should be reviewed 'on screen,' further supported by entry documentation, physically inspected, sampled, or permitted to proceed into domestic commerce without further evaluation. FDA can use the data in the entry system to track an imported item that negatively affected the public health.

    At a minimum, this procedure requires filers who fail an evaluation to implement an FDA-approved Corrective Action Plan (CAP) and to pass a tightened evaluation (more stringent criteria) before obtaining, maintaining or regaining the privilege of paperless filing. This protects public health by insuring quality improvement and reporting compliance for imported articles that FDA regulates. It also ensures FDA is notified when articles appear to be violative that have previously been offered for entry.

    During FY 2003 ORA continued to develop the policies and practices that govern the monitoring of filers. Expanded Import activities supporting project Liberty Shield increased FDA's understanding of the problems associated with appropriate monitoring of Filer activities. During FY 2004 FDA will continue to develop and apply methods to evaluate filer accuracy that are consistent with evolving security and import regulation practices.

  • Performance: In FY 2004, FDA performed 1,745 filer evaluations.For FY 2005, FDA has drafted a new version of the filer evaluation that is currently under review in the Agency. This version of filer evaluation practices substantially is modified to reflect increasing needs to assess data integrity. Due to this modified practice the time it takes to do a filer evaluation will more than likely increase dramatically which will impact the number of filer evaluations completed in FY 2005 and FY 2006.

    This goal is an agency wide goal and performance data will include activities from all five program areas. The majority of the performance and resources are from the Foods program so this goal is shown in the Field Foods section for illustrative purposes.

  • Data Sources: Field Data Systems

4. 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. (19016)

  • Context of Goal: In FY 2001 FDA refused about 18,000 products offered for import entry into the U.S. Because of safety and security concerns it is important for FDA to be sure that these goods do not slip into domestic commerce but are in fact sent out of the country. FDA monitors this activity in conjunction with Customs in a category of action described as follow up to refusals.

    If a product is refused admission, it must be destroyed or exported under Customs' supervision within 90 days of receiving the Notice of Refusal. FDA is responsible for the protection of the U.S. public regarding foods, drugs, devices, electronic products and cosmetics, and that responsibility exists until the violative article is either destroyed or exported. 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 is exported or destroyed. In cooperation with CBP, FDA will, at times, supervise destruction or examine products prior to export in order to ensure that the refused product is actually exported. In other cases FDA relies on notification from CBP that the refused product has been destroyed or exported. During FY 2004, FDA will continue to develop the policies and practices that will govern the monitoring of the export of refused goods, and issue assignments that are designed to refine practices and assess the amount of time that is required to perform these evaluations. FDA will also implement an interim way to count these events. FDA will integrate the collection of data on the export of refused entries into field data systems as the systems are upgraded. ORA and the product Centers will identify product categories and charged violation combinations that represent the greatest risk to consumers to develop a risk-based strategy for targeting exports of refused shipments for supervision and tracking.

  • Performance: In FY 2004, FDA performed 4,905 examinations of FDA refused entries as they are delivered for exportation to ensure that the articles refused by FDA were being exported. This goal is an agency wide goal and performance data will include activities from all five program areas.
  • Data Sources: Field Data Systems

5. 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.) (11020)

  • Context of Goal: FDA applies a risk based strategy to the inspection of the food establishments in its inventory. High risk foods refer to those that may contain hazards that have a high potential for causing serious adverse health consequences that would result in FDA Class I recalls. These include foods that may contain bacterial or viral pathogens, biological toxins, allergenic substances, bovine spongiform encephalopathy (BSE) infective materials, as well as foods such as infant formula and medical foods due to a potential hazard from the omission or improper fortification of the nutritive ingredients.

    High risk establishments are manufacturers, packers and repackers of foods processing products that include: modified atmosphere packaged products; acidified and low acid canned foods; seafood; custard filled bakery products; soft, semi-soft, soft ripened cheese and cheese products; un pasteurized juices; sprouts or processed leafy vegetables; fresh vegetables shredded for salads and processed root and tuber vegetables; sandwiches; prepared salads; infant formula; and medical foods. Additional high-risk products have been identified in recent years include establishments that manufacture a product that may contain a commonly allergenic substance (milk, eggs, fish, crustaceans, tree nuts, peanuts or soybeans), and dietary supplements that may contain bovine derived ingredients from BSE countries identified in the USDA regulation (9 CFR 94.18). Excluded from high risk are the non high risk establishments. These establishments include non-refrigerated warehouses, growers, and dealers, as well as establishments that sell with no product manipulation such as shippers and labelers.

    The FDA inventory of high risk establishments is dynamic and subject to change. Changes in the inventory can occur (1) because establishments go in and out of business, (2) establishments either no longer make high risk foods, or begin production of high risk foods, (3) establishments that either enter or withdraw from interstate commerce, and new establishments entering the market place and have not been previously inspected, (4) FDA establishes new rules to reduce emerging microbial hazards or expands existing programs, (5) the underlying scientific information and understanding may help target the source of the hazard and thereby change number and types of firms and (6) data received from the Food Registration database

    High risk 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. As an example, establishments will be subject to differing inspection intervals within this inspection strategy just as Low Acid Canned Food establishments have a varying inspection cycle based on risk within the current strategy. Because domestic Low Acid canned food manufacturers have a long history of exemplary compliance with FDA's good manufacturing practices and individual establishments effectively monitor their individual processing procedures, FDA believes that these establishments need to be inspected only once every three years.

    The current high risk strategy considers food hazard information from various sources such as outbreaks, recalls, and consumer complaints as well as food analysis, epidemiological data, inspectional data and formal risk assessments. This information will be used to update currently listed commodities and establishments as well as the overall high risk inventory of firms. Indeed, the FY 2005 and FY 2006 high risk inventory of firms is estimated to be at approximately 6,800 firms. This decrease from previous years reflects the current high risk strategy employed by FDA and the change in the status of inspection intervals for certain establishments such as cheese and LACF firms which have achieved a high level of compliance that no longer warrants an inspection interval of once or even twice a year.

    As an example, FDA recently completed a risk assessment of 26 ready-to-eat foods for listeriosis from the pathogen Listeria monocytogenes. This assessment ranked risk into categories from very high to low dependant on estimated risk per serving and on an annual basis. There are also foods that contribute to foodborne disease that are not ready to eat such as shell eggs and certain produce items that have caused outbreaks and are under evaluation.

    Important features of this strategy will be reducing the occurrence of illness and death by focusing resources on manufacturing establishments and other industry components that have the greatest potential for greatest risk. This will result in different inspection frequencies as establishment processes come under control and present less risk or as new risks are identified. This strategy will also allow FDA to better address and communicate to our stakeholders about food safety risks.

    As an added effort in the area of high-risk foods, FDA will determine the occurrence of the 5 CDC-identified foodborne illness risk factors and environmental risk factors in the inventory of the regulated Interstate Travel Conveyance facilities, in order to establish a reduction in foodborne illnesses over time. Interstate Travel Conveyance facilities serve 900 million meals and snacks annually. FDA's efforts will include the inspection of food and environmental facilities, such as water, wastewater and solid wastes in airline, train, bus and cruise ship airports, hubs, stations and port facilities. In FY 2004, FDA will develop a baseline data collection project that will include developing forms, a statistical validity assessment, development of a sampling plan, conduct training, provide technical support, establish a pilot study and revise the baseline project as needed. Additionally, FDA will inspect 95 percent of the official establishment inventory (OEI) of the regulated Interstate Travel Conveyance facilities to collect the baseline data. These data collection activities would include the inspection of these high-risk facilities.

  • Performance: In FY 2000, the number of high-risk food inspections was approximately 5,700 or 91% of the identified possible inventory of high-risk product/process domestic firms. In FY 2001, the Agency accomplished 78% of the identified possible 6,800 inventory of high-risk product/process domestic firms. The reason FDA fell short of achieving this goal was because the Agency had to concentrate its resources and focus on an even greater threat of BSE that was breaking out in Europe at the time.

    In FY 2002, FDA conducted 6,784 domestic inspections of firms that produce "high risk" foods (through ORA and the states, under FDA auspices). This exceeded FDA's goal to annually inspect 95% of the estimated 7,000 "high risk" domestic food establishments.

    In FY 2003, FDA conducted 7,363 domestic inspections of firms that produce "high risk" foods (through FDA's Office of Regulatory Affairs and the States, under FDA auspices). This exceeds the goal to annually inspect 95% of the estimated 7,000 "high risk" domestic food establishments. The field performed more high risk inspections than the target because of changes in the risk category of firms between the time that the inventory was calculated and the inspection was conducted. The food firm inventory and firm risk categories change even when the overall totals appear stable. The field often needs to perform more firm inspections than the target to be sure of meeting the high risk target. In FY 2004, FDA performed 7,597 inspections of high-risk domestic food establishments.

  • Data Sources: Field Data Systems

6. 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. (11027)

  • Context of Goal: Three federal government agencies share responsibility for the regulation of pesticides. The Environmental Protection Agency (EPA) registers and approves the use of pesticides and sets tolerances (the maximum amount of residue that is permitted in or on a food if use of that particular pesticide may result in residues in or on food). The USDA's Food Safety and Inspection Service (FSIS) is responsible for enforcing tolerances in meat, poultry, and certain egg products. FDA is charged with enforcing tolerances in imported foods and in domestically produced foods shipped in interstate commerce. FDA also acquires data on particular commodity/pesticide combinations and carries out its market basket survey, called the Total Diet Study (TDS). In conducting the Total Diet Study, FDA personnel purchase foods from retail outlets four times a year, once from each of four geographic regions of the country. The foods are prepared table-ready and then analyzed for pesticide residues and environmental contaminants. The levels of pesticides found will be used in conjunction with USDA food consumption data to estimate the dietary intake of the pesticide residues.

    Under the regulatory monitoring program, FDA samples individual lots of domestically produced and imported foods and analyzes them for pesticide residues to enforce the tolerances set by EPA. Domestic samples are collected as close as possible to the point of production in the distribution system; Import samples are collected at the point of entry into U.S. commerce. FDA's pesticide program focuses its efforts on raw agricultural products which are analyzed as the unwashed, whole (unpeeled), raw commodity. Processed foods are also included. If illegal residues (those that are above EPA tolerances) are found in domestic samples, FDA can invoke various sanctions, such as a seizure or injunction. For imports, shipments may be stopped at the port of entry when illegal residues are found. "Detention without physical examination" may be invoked for imports based on the finding of one violative shipment if there is reason to believe that the same situation will exist in future lots during the same shipping season for a specific shipper, grower, geographic areas, or country.

    Personnel in FDA Field offices interact with their counterparts in many states to increase FDA's effectiveness in pesticide residue monitoring. In many cases, Memoranda of Understanding or more formal Partnership Agreements have been established between FDA and various state agencies. These agreements provide for more efficient monitoring by broadening coverage and eliminating duplication of effort, thereby maximizing federal and state resources allocated for pesticide activities.

    In planning the types and numbers of samples to collect, FDA considers several factors. These factors include: recently generated state and FDA residue data, regional intelligence on pesticide use, dietary importance of the food, information on the amount of domestic food that enters interstate commerce and of imported food, chemical characteristics and toxicity of the pesticide, and production volume/pesticide usage patterns.

  • Performance: FY 1998 - 8,500 samples (3,600 domestic and 4,900 imports); FY 1999 - 9,400 samples (3,400 domestic and 6,000 imports); FY 2000 - 7,400 samples (2,500 domestic and 4,900 imports).

    In FY 2001, actual performances for pesticide residues and chemical contaminants monitoring was 8,250 (7,600 for pesticide residues including 1,100 TDS and 650 dioxin including 250 TDS). This figure is slightly higher than the figure the Center previously reported as it contains a more accurate accounting of the total number of samples monitored under our regulatory monitoring program and our Total Diet Study program. Thus, FDA analyzed 7,600 samples for pesticide residues which includes 1,100 samples collected for the Total Diet Study. TDS analyzed for pesticide residues and other chemical contaminants in foods consumed by infants and children. The Total Diet Study is a major element of FDA's pesticide residue monitoring program. Some of the samples collected under the Total Diet Study have also been monitored for dioxins in the past couple of years and, possibly, for other chemical contaminants as well. Therefore, the samples collected for the TDS analyzed for pesticide residues and other chemical contaminants should be counted as "actual performances" under the "pesticides and environmental contaminants". The total number of samples analyzed for dioxins was 650 for a total actual performance of 8,250. FDA must maintain resource levels devoted to the sampling and analyses of pesticide and environmental contaminants, specifically dioxin, not only to ensure that the U.S. food supply is safe, but also to reduce dietary exposure. In FY 2002, FDA collected and analyzed 10,700 food samples to monitor for pesticides and environmental contaminants. This exceeded FDA's goal to collect and analyze 8,000 samples.

    In FY 2003, FDA collected and analyzed 11,331 food samples for pesticides and chemical contaminants. Our goal was to complete 8000 samples by the end of FY 2003. FDA exceeded its goal by 3,331 at 142% of our intended target.

    In FY 2004, FDA collected and analyzed 12,682 food samples for pesticides and chemical contaminants.

  • Data Sources: FACTS, CFSAN web site.

7. Expand federal/state/local involvement in FDA's eLEXNET system by having 105 laboratories submit data in the system. (19013)

  • Context of Goal: 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. 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.

    Beginning in FY 05 and continuing in FY 06, the eLEXNET program will focus on strengthening existing programmatic activities to build eLEXNET capabilities to better handle its new uses and to meet the growing demands on the system. These activities include:

  • Increased security--the eLEXNET program is the primary communication tool for the Food Emergency Response Network (FERN), a network of federal, state, and local food testing laboratories that will respond in the event of a terrorist incident involving the Nation's food supply and will be handling information on methods of sample analyses and reporting of analytical results. As such, eLEXNET must continue to expand its security infrastructure to support the needs of the FERN. This includes enabling the program to communicate with the Department of Homeland Security to feed into their early alert system.
  • Quality-- as the number of labs contributing to eLEXNET increases; it becomes increasingly difficult to ensure the quality of the data being entered. In view of the importance that DHS and the National Security Council are placing on this program, ensuring data quality and integrity is vital. In addition, the program must continue to increase its ability to communicate seamlessly and flawlessly with other early alert systems using national data standards. The infrastructure of the eLEXNET program must be strengthened to support the increased scrutiny its data is undergoing.
  • Outreach--eLEXNET is a storehouse of useful and timely data that enables health officials to make assessments regarding trends and risks and provides the infrastructure for an early-warning system that identifies hazardous foods. However, the program must increase its outreach to the proper officials to ensure the data system is being used to make good decisions about sampling plans and risk assessments.
  • Expansion into international partnerships and strengthening those that are already being formed with Canada and Mexico through the Trilateral Agreement will result in a continent-wide food security network. Developing relationships, performing the assessments, integrating systems, training staff, and piloting their inclusion into eLEXNET will require a significant expenditure of time and resources for each individual international partner.
  • Performance: Performance is measured by the number of laboratories submitting data into the eLEXNET system. eLEXNET was released as a proof-of-concept system in FY 2001 to 14 laboratories (7 regional FDA, one regional USDA, and 6 state and local agriculture and public health laboratories). The eLEXNET partnership included 55 laboratories submitting data to the system at the end of FY 2003. In FY 2004, FDA met the goal of 79 laboratories, despite a 50% reduction in funds. To achieve the goal, FDA concentrated available funds on meeting this target number of laboratories. Meeting this goal came at the expense of funding necessary enhancements and changes to the system that would further the usability and functionality of eLEXNET. The FY 2005 goal was revised to reflect the challenges produced by the FY 2004 cuts. Assuming uninterrupted funding, we can project bringing on another 16 labs during FY 2005, bringing the total goal for FY 2005 to 95 participating labs. FY 2006 goals will reflect the refocusing of the program, with a total goal of 105 participating labs.
  • Data Source: ORA will track the number of participating eLEXNET laboratories.

8. Increase risk-based compliance and enforcement activities to ensure product quality. (Formerly:Inspect 55% of registered high-risk human drug manufacturers.) (12020)

  • Context of Goal: This goal has been expanded to provide a broader perspective for drug compliance activities. Over the last few years, FDA has conducted a major effort to bring a 21st Century focus to the regulation of pharmaceutical manufacturing and product quality by providing high quality, cost-effective oversight of industry manufacturing, processing and distribution. FDA focuses on product quality standards and compliance by manufacturers with the GMP regulations to ensure that the highest possible quality products are marketed. We ensure the latest technological advances are encouraged, including application of the requirements of Part 11 regulations.

    Our staff provides inspection assessments of conformance with current good manufacturing practice requirements for self correction and improvement of operations, and we assist Industry in voluntary recalls of products from the market and in the investigation, evaluation, and corrections of the conditions and practices which led to the recalls. We provide certificates of conformance with current good manufacturing practice by the Industry for use in facilitating export of US pharmaceutical production to countries with limited regulatory systems, and we provide consultation to industry and coordination of FDA program activities to alleviate drug shortages in the US market.

    The target for FY 2006 continues the trend of measuring performance toward inspecting high-risk establishments. Earlier, as a part of the Pharmaceutical GMP's for the 21st Century initiative, FDA changed the performance target for manufacturing inspections from 20 percent of all drug establishments to 55 percent of high risk establishments. This change demonstrated implementation of a risk-based approach that focuses scarce inspectional resources on drug establishments where FDA intervention is likely to achieve the greatest public health impact. This approach will encourage more inspections at drug establishments where FDA can intervene to address or prevent manufacturing problems that would have the most significant adverse effect on drug safety and effectiveness. This goal measures performance for the inventory of registered domestic drug establishments which operate under high risk conditions. In fiscal year (FY) 2003, FDA, using a basic risk management approach, identified three categories of potentially higher-risk pharmaceutical manufacturing sites for prioritizing inspections: sites making sterile drugs; sites making prescription drugs, and sites of new registrants not previously inspected by FDA. In FY 2004, FDA will continue to modify the list of 'high risk' firms based on lessons learned from the FY 2003 approach. Additionally, FDA will continue to develop a more quantitative risk model to help predict where FDA's inspections are most likely to achieve the greatest public health impact for FY 2005.

    In addition, FDA will continue to develop a more quantitative risk model to help predict where FDA's inspections are most likely to achieve the greatest public health impact for FY 2005. This new risk model may cause a significant change in the FY 2006 inventory. The model will help the Agency predict where its inspections are most likely to achieve the greatest public health impact. The model will include risk factors relating to the facility such as compliance history and to the type of drugs manufactured at the facility. The model will also include risk factors relating to the manufacturing processes and the level of process understanding.

  • Performance: In FY 2003, FDA began implementing several risk management strategies, and changed the focus of this goal to concentrate on "high risk" inspections. In FY 2003, FDA exceeded the goal, despite a large and unforeseen increase in the number of high- risk firms. FDA conducted 584 inspections of971registered high risk drug firms(including medical gas manufacturers), exceeding the number of planned inspections by nearly 200. The inventory of high risk firms increased for several reasons .Additional high-risk drug firms were identified throughout the year. There was also an increase in the number of initial registrants that had to be inspected. Since most initial registrants are not considered high-risk after their first inspection (repackers, relabelers, control labs), FDA does not expect most of these firms to be included in the FY 2004 high risk inventory.FDA also has decided not to include medical gas manufacturers as "high risk" firms in future years, though they were counted in the FY 2003 high risk inventory. Although the target for FY 2004 and 2005 is still 55%, this remains a challenging goal because of the increasing inventory, as well as an increase in the difficulty of those inspections. In FY 2004, performed 481 inspections of high- risk drug firms.

    There was no high- risk coverage percentage established in FY 2002, although FDA did meet its FY 2002 goal of inspecting 20% of registered human drug manufacturers, repackers, relabelers and medical gas repackers. In FY 2002, FDA inspected 23% of 6,698 total firms (~1,540 inspections).

  • Data Sources: The inventory of high- risk drug establishments is based on compliance status reports developed from the Field Accomplish and Compliance Tracking System (FACTS) and is augmented by a list of targeted establishments generated by the CDER, based on their judgment of those establishments that meet the high risk criteria defined above.

9. 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. (13012)

  • Context of Goal: This includes inspections done by FDA directly, or through state contracts or partnership agreements. The law requires FDA to conduct inspections of certain manufacturing facilities once every two years. The inspections are conducted to ensure compliance with Current Good Manufacturing Practices (CGMP's), and ensure the purity of the biological products. There are currently an estimated 2,700 establishments in the Biologics Program inventory covered under this statute. The establishments include high-risk establishments such as blood collection facilities, plasma fractionator establishments and vaccine manufacturing establishments. There are 1,665 additional establishments in the Biologics Program inventory not covered under this statute.
  • Performance: In FY 2004, FDA inspected 55% of the 2,648 establishments. In FY 2003, FDA inspected 60% of the 2,662 establishments in the Official Establishment Inventory, exceeding the goal of 50%.
  • Data Sources: Program-Oriented Data System, Official Establishment Inventory.

10. Ensure the safety of marketed animal drugs and animal feeds by conducting appropriate and effective surveillance and monitoring activities. (14009)

  • Context of Goal: As of FY 2005, this goal has been revised to reflect a comprehensive display of the performance and cost of CVM field surveillance and compliance work. FDA exercises considerable discretion regarding the frequency and comprehensiveness of inspections. The Animal Drugs and Feeds Program statutory obligation requires inspection of all regulated animal drug and medicated feed establishments once every two years. Routine inspections have lower priority than inspection of firms producing high profile products. This has an impact on the pre-approval process that requires a "recent" inspection before approval of a new animal drug. This includes inspections done by FDA directly, or through state contracts or partnership agreements on manufacturers, repackers and relabelers (drugs), and manufacturers and growers requiring a Medicated Feed Mill License.

    FDA has also sought to protect the public through the development of a comprehensive strategy of education, inspection and enforcement action on industry. These activities were initiated to ensure compliance with the Bovine Spongiform Encephalopathy (BSE) feed regulations. Using an inventory of all known renderers and feed mills processing products containing prohibited material, FDA will continue to conduct inspections to determine compliance with the BSE feed rule. Inventories of these firms may vary from year to year based on changes at the firm such as consolidations, business closures, relocations, etc. FDA will continue to update and improve the inventory of firms with information from the mandatory feed registration system, from states and other sources. The estimated inventory number of renders and feed mills processing products containing prohibited materials is 570 for FY 05 and FY 06. The FY 05 BSE funding increase will primarily support funding of state BSE inspections, on-farm BSE inspections, and BSE monitoring and control infrastructure grants so that the states can perform an additional 2,500 inspections, improve state and federal information on the inventory of animal feed firms and firms handling prohibited materials, and strengthen state infrastructure to monitor, and respond to potential feed contamination with prohibited materials.

  • Performance: FY 99 = 25%; FY 00 = 39%; FY 01 = 37%; FY 02 = 55%; FY 03 = 58.8%. FY 04 = 55%. In FY 99, 25% of registered animal drug and feed establishments were inspected. The FY 1999 actual performance fell short of the 27% target based on the fact that the initial inspection percentages were estimates, due to the complexity and number of inspections, and re-inspections. In FY 2000, FDA inspected 39% of the establishments in the Official Establishment Inventory, exceeding the goal of 27%. Due to a few problems resulting from the transition to a new database (FIS to FACTS) in FY 2000, some adjustments in counting the inventory and inspectional coverage were necessary.

    In FY 2001, the program accomplished 37% biennial inspection coverage of registered animal drug and feed establishments. In FY 2001 the goal was not met due to the increase in reported cases of BSE in Europe, in FY 2001 FDA concentrated its efforts on performing BSE inspections in the U.S. This intense inspection effort was intended to prevent an outbreak of BSE in the U.S. by completing 100% inspection of all firms. In FY 2002 and FY 2003 respectively, FDA inspected 55% and 58.8% of registered animal drug and feed establishments. In FY 2004, FDA inspected 55% of registered animal drug and feed establishments.

    FDA's regulation 21 CFR 589.2000 (Animal Proteins Prohibited From Use in Animal Feed) became fully effective August 4, 1997. The purpose of the regulation is to prevent the establishment and amplification of BSE through animal feed. The regulation prohibits the use of certain proteins derived from mammalian tissue in feeding to ruminant animals. FDA has developed a three-pronged approach in its efforts to realize 100% compliance with the 1997 feed rule—education, a strong and visible inspection presence, and enforcement action. Due to the increase in reported cases of BSE in Europe, in FY 2001 FDA concentrated its efforts on performing BSE inspections in the U.S. This intense inspection effort was intended to prevent an outbreak of BSE in the U.S. by completing 100% inspection of all firms. Performance was achieved in FY 2002, FY 2003, and FY 2004. The goal was revised in FY 03 to reflect FDA's focus on inspection of firms which process products containing prohibited material.

  • Data Sources: Field Accomplishment Compliance Tracking System (FACTS) [formerly known as the Program Oriented Data System (PODS)], Official Establishment Inventory.

11. Conduct 295 domestic and foreign BIMO inspections with an emphasis on scientific misconduct, data integrity, innovative products, and vulnerable populations. (15025)

  • Context of Goal: In FY 2006, FDA plans to conduct 295 BIMO Inspections. Traditionally, CDRH BIMO's approach to inspections has been focused on data audits of Pre-Market Approval (PMA) applications. This approach has been successful in that we have been able to provide the review divisions a validation of the data submitted in marketing applications. However, these inspections are retrospective and have very little impact on ongoing clinical trials. In addition, compliance rates over the past several years have changed minimally. The intent of the description included in the BIMO Goal Statement is to reflect that FDA is assigning more inspections earlier in the process, during the investigational device exemption (IDE) phase. The agency hopes to have a greater impact by identifying systemic problems and focusing on exploitable or vulnerable populations. The focus of these types of inspections is process, the informed consent, IRB review and approval, data monitoring, and data collection rather than data verification. CDRH has approximately 1000 active Investigational Device Exemptions (IDEs) of high-risk investigational devices (e.g., artificial hearts, drug eluting stents). CDRH is interested in expanding our presence with the regulated industry through a risk-based inspection strategy. This strategy places more emphasis on (1) the detection of scientific misconduct, (2) data auditing and validation to support the device review process (greater importance on time constraints of MDUFMA and studies relying principally on foreign data), (3) innovative devices with high public health impact, and (4) vulnerable populations (elderly, minorities, pediatrics, etc.).
  • Performance: In FY 2004, FDA conducted 354 inspections.In FY 2003, FDA met its goal of conducting 364 inspections. This goal was a new reporting commitment in FY 2002, and FDA met this goal by conducting 358 inspections. In FY 2001, 238 BIMO inspections were conducted.
  • Data Sources: CDRH Field Data Systems.

12. Utilize Risk management to target inspection coverage for Class II and Class III domestic medical device manufacturers at 20 percent of an estimated 5,540 firms. (15005.01)

  • Context of Goal: This goal includes inspections done by FDA directly, or through state contracts or partnership agreements on Class II and Ill domestic medical device manufacturers. It does not include any inspections conducted under the Inspection by Accredited Persons Program. Class II and Ill manufacturers are required by statute to be inspected at least once every two years. The inventory of Class II and III medical device firms is estimated at 5,540 by FY 2005. During FY 2002, the Center has developed an estimated inventory of 1,009 High/Significant Risk devices based largely on the Center's established critical device list. These high/significant risk devices (e.g., Cardiovascular Heart Valves) have been targeted for inspections in FY 2004. Reuse inspections have been incorporated into the domestic high/significant risk inventory. FDA plans to conduct 100 reuse hospital inspections in FY 2004, and these will need to be conducted with base resources. During FY 2003, inspections will be reserved for those hospitals reprocessing higher risk Class II and III devices. The approximately 4,000 Class I lower risk domestic firms will not be inspected on a routine basis: only "for cause" to follow up on problems identified in recalls or reported by the public.
  • Performance: FDA exceeded its FY 2004 performance goal by inspecting 1,414 or 25% of 5,576 domestic high risk Class II and Class III medical device manufacturers.FDA met its FY 2003 performance goal by inspecting 1428 or 26% of approximately 5,401 domestic high risk Class II and Class III medical device manufacturers.In FY 2002, FDA met its performance target by inspecting 1062, or 20 percent, of approximately 5,300 domestic high risk Class II and Class III medical device manufacturers. FDA's statutory performance requirement is 50 percent. With the exception of those inspected for cause, many manufacturers of low risk Class I devices have never been inspected. To develop a better understanding of their compliance rate a small number of such firms were inspected.

    Medical devices comprise a wide array of products that have become medically and technologically more complex. While the medical device industry is growing and revolutionizing, FDA's inspection coverage is not keeping pace with the new device firms, and domestic recall rates are increasing. Medical devices and radiological health inspection resources have been reduced by more than 23 percent since FY 1995 and these resource limitations have put coverage below critical mass.

    FDAMA exempts many lower risk devices from pre-market approval, and relies instead on postmarket quality systems conformance. Firms may declare conformity to standards or quality systems requirements as part of streamlining premarket clearance. However, FDA will be unable to routinely monitor quality systems conformance for lower risk firms.

  • Data Sources: CDRH Field Data Systems.

13. Utilize Risk management to target inspection coverage for Class II and Class III foreign medical device manufacturers at 7 percent of an estimated 2,500 firms. (15005.02)

  • Context of Goal: Inspection coverage is expected to be 9 percent in FY 2004 and 7 percent in FY 2005 and FY 2006. FY 2005 and FY 2006 targets are 7 percent due to resource constraints on funding for foreign inspections. The approximately 2,500 Class I lower risk foreign manufacturers will not be routinely inspected, only for cause. This goal includes joint inspections of high-risk device manufacturers with European Union Conformance Assessment Bodies although implementation of the Mutual Recognition Agreement with the EU has not been as successful as anticipated. To date, less than 25 percent of the several hundred foreign manufacturers contacted have agreed to participate in the MRA Inspection Program. Most choose not to participate but cite a preference for an FDA inspection. In the long term, if the MRA is successfully implemented, it could reduce the number of foreign firms that FDA will need to inspect. FDA supports a web site dedicated to MRA activities, including the implementation plan, eligible device lists, MRA meeting minutes, and the list of nominated US and EU Conformity Assessment Bodies (CABs) that are participating in confidence building activities. The web site is: http://www.fda.gov/cdrh/mra/index.html.
  • Performance: FDA exceeded its FY 2004 performance goal by inspecting 295 or 12% of approximately 2,500 manufacturers.The agency met its FY 2003 performance goal by inspecting 225 or 9% of approximately 2,500 of registered foreign Class II and Class III Medical Device manufacturers. FDA almost met its FY 2002 performance goal of inspecting 9 percent of registered foreign Class II and Class III Medical Device manufacturers. In FY 2002, FDA's foreign inspection rate was 8 percent and 200 inspections were conducted compared to 266 inspections conducted in FY 2001. FDA did not reach the 9% coverage goal since the international climate post '9/11/01' adversely impacted foreign travel. The compliance program is focused on the improvement of enforcement actions by redirecting current resources to high‑risk devices such as implants.
  • Data Sources: CDRH Field Data Systems.

14. Establish and maintain a quality system in the ORA Field Labs which meets the requirements of ISO 17025 (ASCLD for FCC) and obtain accreditation by an internationally recognized accrediting body. (11041)

  • Context of Goal : 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 will provide a mechanism for harmonizing and strengthening processes and procedures, thereby improving the quality of operations and the reliability of FDA's science.

    The testing and calibration laboratory community has accepted the international standard ISO 17025 "General requirements for the competence of testing and calibration laboratories" as the gold standard for assessing the competence of laboratories to produce technically valid data and results. A global network has formed so that the results from accredited laboratories are mutually accepted. In many technical sectors, accreditation to ISO 17025 has become a requirement for doing business. This applies equally to laboratories in government, academia, and private industry.

    FDA's laboratories currently operate under a variety of formal and informal quality management systems. All of these systems have the same aim - to assure the quality of laboratory results upon which regulatory decisions are made. However, these systems differ in their rigor and in the amount of independent oversight exercised. An FDA quality management system that is accredited to international standards will enable our managers to better maintain high quality laboratory operations, to more easily control resources, and to act with more confidence in meeting the needs of their customers and stakeholders. More effective operations will result in greater regulatory impact and better consumer protection. Uniform laboratory procedures will enhance data reliability and resource sharing with our domestic and international partners.

    FDA's quality management systems include risk management principles. Since laboratories receive accreditation for specific test technologies or methods, we will use risk assessment tools to determine which test technologies and/or methods will be accredited. The quality management system incorporates risk management in targeting resources and controlling processes on an ongoing basis. Targeted resources result in laboratories equipped to respond to national emergencies, food-borne outbreaks, and emerging analytical problems. Controlled processes result in documented procedures and activities that withstand domestic and international scrutiny.

    Through laboratory accreditation, FDA will maintain its reputation as a source of scientifically sound information and guidance. Other known benefits of quality systems include preservation of institutional knowledge and increased employee satisfaction and retention. Over the long term, the quality management system implemented in FDA laboratories can serve as a model for managing other FDA regulatory and business processes.

    The thirteen ORA Field Laboratories are currently implementing a new quality system in accordance with the updated Laboratory Manual that issued in August 2003. The manual was written to accommodate the requirements of ISO 17025 - General requirements for the competence of testing and calibration laboratories and other changes in our regulatory policies and procedures. ORA selected The American Association for Laboratory Accreditation (A2LA) as the accrediting body on the strength of its experience and its recognition by the international accrediting community. The Forensic Chemistry Center has elected to use the American Society of Crime Lab Directors (ASCLD) as its accrediting body because of their unique mission.

    Laboratory accreditation is an important commitment by FDA. It recognizes the need for our laboratories to have international recognition and parity; share data and other information of other accredited labs around the world; share a common set of policies and procedures in improving operations and uniformity; and, provide excellent work products that are defensible and consistent. With accredited laboratories, the credibility of FDA's analytical results will be greatly enhanced, both nationally and internationally. The reliability of data is critical in facilitating the sharing of data and in FDA and our partners being willing and able to take regulatory actions without duplicating the analyses.

    Summary of Accreditation Process: Each FDA laboratory must be accredited independently based on its own program work, laboratory capabilities, and personnel competences - based on uniform guidance provided by the recently updated ORA Laboratory Manual. Each laboratory goes through four steps: (1) create required procedures and work instructions; (2) implement the quality system and train staff; (3) perform internal pre-audit; and, (4) apply for final assessment. The entire process normally takes 3 to 5 years to complete. ORA can significantly reduce this time by sharing procedures, work instructions and forms among labs doing similar work. Modifications in several of its on-going programs, such as the National Check Sample Program, have been made to meet the proficiency testing requirements of the standard. Additional support will be needed to continue to meet the requirements for equipment qualification and calibration as well as data storage and retrieval.

    Annual Accreditation Maintenance Requirements: In order to perform the required audits and reviews, the quality system must be in place and operating - generating records according to the requirements established in the quality manual entitled, "ORA Laboratory Manual." As the system is developed and put in place, the staff must be trained on the new procedures and what is expected of each person. This training must be documented. Part of the final assessment includes one-on-one interviews with the staff to discuss "how they perform their work;" "what is required by the quality system"; and, "why."

    Maintenance of Laboratory Accreditation in the out-years includes an initial re-assessment at the end of one year to ensure that the ORA Laboratory is still complying with the requirements of the quality system. After that, the accrediting body will complete a bi-annual assessment on the ORA Laboratory. There is also a requirement for a documented management review meeting to assess the findings of the internal audit and to review the overall operations of the laboratory.

  • Performance: This goal is new for FY 2005. However, the Denver District Laboratory has been accredited according to ISO 17025 and requires ongoing maintenance of accreditation activities. The Forensic Chemistry Center (FCC) is awaiting final disposition of its application; and, four additional laboratories have completed the internal pre-audit process.
  • Data Sources: Field Data Systems.

 

Other Activities Performance Goals

Performance Goals Targets Actual Performance Reference
 1. Reduce the number of review levels in the Agency to help streamline operations. (19001)

FY 06: NA

FY 05: NA

FY 04: ORA to be completed by the end of 1st quarter. Accomplishment summary due to HHS by January 2004.

FY 03: Develop and implement a plan to delayer CBER, CFSAN, CDRH, OC and ORA.

FY 02: Develop and implement a plan to delayer NCTR, and CVM.

FY 06:

FY 05:

FY 04:Completed development and implementation plan to delayer ORA at end of 1st quarter.

FY 03: Completed development and implementation plans to delayer CBER, CDER, CDRH, CFSAN and OC.

FY 02:Developed and implemented a plan to de-layer NCTR, CVM and OC.

G

Improved Financial Management

8

Efficiency goal

2. Implement 'shared services' concept and consolidate selected functions in the agency. (19002)

FY 06: NA

FY 05: NA

FY 04: Implement the Shared Service organization for those functional areas transferred to the organization. Complete field migration of shared services and add field staff to ERIC.

FY 03: Begin implementation of shared services concept in accordance with the Booz, Allen and Hamilton (BAH) Administrative Consolidation Study.

FY 06:

FY 05:

FY 04: Completed implementation of OSS organization, including Field migration. Effective March 22, 2004, the Field employees began reporting to the Office of Shared Services.

G

Improved Financial Management

8

Efficiency goal

 3. Increase the number of Commercial Activities that will be reviewed for competitive sourcing. (19003)

FY 06: NA

FY 05: (combined with FY 04) Conduct Clerical Study via competition of 350 FTE.

FY 04: (combined with FY 05) Conduct Clerical Study via competition of 350 FTE

FY 03: Review 145.7 FTE

FY 02: Review 72.7 FTE

FY 06:
FY 05:
FY 04: 3/05.
FY 03: 167 FTE
FY 02: 63

G

Improved Financial Management

8

Efficiency goal

 4. Increase the percentage of electronically purchased transactions.* (19004) FY 06: NA
FY 05: NA
FY 04: 92%
FY 06:
FY 05:
FY 04: 99%

G

Improved Financial Management

8

Efficiency goal

 5. Maintain a clean (or unqualified) audit opinion with no material weakness. (19005) FY 06: NA
FY 05: NA
FY 04: Yes
FY 03: Yes
FY 02: Yes
FY 01: Yes
FY 06:
FY 05:
FY 04: Yes
FY 03: Yes
FY 02: Yes
FY 01: Yes
FY 00: Yes
FY 99: Yes

G

Improved Financial Management

8

Efficiency goal

 6. Maintain percentage of contract dollars allocated to performance based contracts (19006) FY 06: 50%
FY 05: 50%
FY 04: 40%
FY 06:
FY 05:
FY 04: 50%

G

Improved Financial Management

8

Efficiency goal

       
 7. Establish an Agency-wide Enterprise Architecture (EA). (19009)

FY 06: NA

FY 05: NA

FY 04: Complete next phase (i.e., critical business and data process that is next in line in priority) of the EA, leveraging outcome of EA developed for CT, Administrative and PDUFA business processes.

FY 03: Complete EA for identified CT and PDUFA business purposes; implement Agency-wide EA governance.

FY 02: Obtain FDA leadership buy-in; award contract for EA development support; initiate the establishment of an EA framework.

FY 06

FY 05:

FY 04: Documented all Core Strategic Business Processes. Matured EA Governance process. Integrated EA with Capital Planning & Investment Control (CPIC) process. Completes target architectures for e-submission and ORA.

FY 03: Completed EA Governance. Documented 90% of CT and PDUFA business processes. Delivered architecture to ORA.

FY 02: Completed all goals

G

Improved Financial Management

8

Efficiency goal

8. 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 Federal Information Security Management Act (FISMA). (19010)

FY 06: NA

FY 05: NA

FY 04: Certification and Accreditation program will be completed, focusing on the FDA's Critical Infrastructure Protection (CIP) inventory. This effort will be further expanded to the non-CIP inventory in FY 04. FDA will implement a Vulnerability Remediation Program, consisting of: policies/ procedures, tools /utilities,reporting & tracking capabilities, and repeatable processes. Continue to ensure 100% compliance of the FDA IT infrastructure and assess the next third of the major systems for GISRA compliance, and perform appropriate risk mitigation.

FY 03: FDA is expected to assess 100% of the FDA IT infrastructure and one third of the major systems for GISRA compliance and provide any needed corrections.

FY 02: NA

FY 06

FY 05:

FY 04: Completed C&A program, including non-CIP assets. Implemented Vulnerability Remediation Program. Ensured 100% compliance of the FDA IT infrastructure and all major systems for FISMA (formerly known as GISRA) compliance, including appropriate risk mitigation.

FY 03: Met FY 03 targets. In addition, initiated Certification and Accreditation program, focusing on FDA's Critical Infrastructure Protection inventory.

FY 02: 100% - The FDA performed comprehensive assessments of OC and NCTR, as well as GISRA compliance reviews of selected major applications and critical IT services.

G

Improved Financial Management

8

Efficiency goal

9. FDA's implementation of HHS's Unified Financial Management System (19017)

FY 06: FDA will pilot an activity-based costing application integrated with HHS UFMS project as part of Prescription Drug User Fee ActIII.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

FY 05: FDA will implement a new core financial management system as part of the HHS UFMS project. The General Ledger and the Payroll interface will be implemented Oct. 1, 2004, and the remaining modules will be implemented April 1, 2005.

FY 04: FDA will hold a conference room pilot to prototype the design and configuration of UFMS. Begin development of FDA's unique interfaces and test global interfaces.

FY 03: Begin data cleanup and preparation for conversion of existing systems to new financial system

FY 02: Prepare for consolidation of accounting operations in the ORA regions reducing the number of payment centers from 15 to 1; standardize on financial system use throughout FDA for accounts payable and Travel.

FY06:

FY 05:

FY 04:FDA held a conference room pilot to prototype the design and configuration of UFMS in February 2004. CRP goals included demonstrating that ORACLE software could meet FDA business needs, having the FDA Center representatives actively participate, having FDA staff drive the software, and proving that FDA implementation strategy would meet DHHS needs. Judging by the extremely positive Independent Validation and Verification (IV&V) Draft Report performed by Titan Corporation, the FDA UFMS team successfully accomplished its slated goals and objectives. From that time until mid- December, progress was made to prepare for the interface testing. On December 17, UFMS teams at FDA performed integration testing on the UFMS.FY 03: Major components of data cleanup have been completed. Travel Manager implementation has been completed throughout the Agency in preparation of UFMS.

FY 02: Goal Met-Completed consolidation of accounting operations and implemented standardized Accounts Payable system. An automated travel system has been implemented in one ORA region and the other four are expected to be completed in FY 03.

G

Improved Financial Management

8

Efficiency goal

 10. Enhance the Agency Emergency preparedness and response capabilities to be better able to respond in the event of a terrorist attack. (19008)

FY 06: Enhance functionality and continue deployment of the National Incident Management System throughout the Agency (HQ, Centers, Field offices).

FY 05: Develop the Agency's Emergency Operations Network.

FY 04: Develop Crisis Management Plan for CT. Develop the Agency's Emergency Operations Network.

FY 03: Radiological Emergency Response Plan and the Chemical and Biological Emergency Response Plan will be reissued

FY 02: Enhance the Agency Emergency Preparedness Plan to establish protocols for responding to terrorist attacks.

FY 06:

FY 05:

FY 04:Designed, developed, and implemented fully certified and accredited EON IMS that is in use by FDA OCM OEO, September, 2004.

Issued Radiological Emergency Response Plan-Version 2.0-December 12, 2004;

Chemical and Biological Emergency Response Plan-Version 3.0-January 26, 2004;

Bovine Spongiform Encephalopathy Emergency Response Plan-Version 5.0-December 24, 2003; and

FDA Crisis Management Plan-Version 1.0-September 1, 2004.

Developed and conducted FDA Radiological Functional Exercise-March 17, 2004; FDA Chemical/Biological Functional Exercise-May 12, 2004.

Participated in interagency meetings to plan TOPOFF 3, a full-scale, fully functional counterterrorism exercise, to take place in April 2005.

Recommended and implemented the creation of a new workgroup under the Trilateral Cooperation (Canada, U.S., Mexico) for emergency preparedness and response; acted as the first chair of the new workgroup and coordinated and participated in the second trilateral food terrorism exercise in June 2004.

FY 03: Radiological Emergency Response Plan, Version 1 was issued September 30, 2003. Chemical and Biological Emergency Response Plan, Version 1, was issued September 30, 2003.

FY 02: Radiological Emergency Response Plan, issued March 2002 (draft 1), currently being redrafted based on comments received and exercises conducted. Chemical and Biological Emergency Response Plan, issued June 4, 2002 (draft 1), currently being redrafted based on comments received and bioterrorism exercises conducted in FY 02.

2

1. Reduce the number of review levels in the Agency to help streamline operations. (19001

  • Context of Goal: FDA is striving to reduce the number of review levels for decision making within the Agency to no greater than four, which is consistent with the President's management initiatives and Departmental guidelines. This goal is in line with the Department's consolidation initiative. Reduction of review levels will allow for a more effective structure and a streamlined organization, as well as increase the span of control to some extent for managers across the Agency. There are, however, limits to span of control ratios at FDA. This is because FDA is a knowledge-based organization, which utilizes complex scientific systems and oversees research activities. Large spans of control are generally more appropriate for production and transaction-based organizations. FDA managers are frequently managing research and development or scientific activities, where large spans of control are not possible or desired.
  • Performance: As of October 2002, the Center for Veterinary Medicine, the National Center for Toxicological Research, and the Office of the Commissioner have eliminated organizational components below the fourth management level. Additionally, in FY 2002, FDA has consolidated from seven Personnel Offices to one. In FY 03, FDA completed development and implementation plans to delayer CBER, CDER, CDRH, CFSAN and OC. ORA is scheduled for review during the first quarter 2004.
  • Data Sources: FDA Organizational charts, personnel databases, and functional matter experts.

2. Implement shared services concept and consolidate selected functions in the Agency. (19002)This goal will be no longer be applicable in FY 05

  • Context of Goal: FDA is aligning itself with departmental guidelines for the consolidation of selected functions across the Agency. In FY 03, detailed process design and organizational design work was done to ensure the shared services organization is positioned to provide the highest level of service to customers in the most efficient way. "Stand up" of the shared services organization began October 1, 2003 (FY 04). The Office of Shared Service is a customer-focused organization in which business units establish service priorities and services are tailored to meet the individual needs of business units. Service level agreements are executed between administrative service providers and customers [business units]. Business units are defined as the various FDA programs- e.g.,the Centers, ORA, etc. The shared service organization is governed by a group which includes representatives of both providers and customers. Performance is benchmarked against 'best practices' in internal and external organizations. The shared services model will help FDA to focus on its 'core business', create satisfied customers and employees; leverage technology and information; and more effectively manage costs.
  • Performance: FDA successfully transitioned administrative services from Headquarters and the Centers to the Office of Shared Services in October 2003. The Office of Regulatory Affairs (field services) and National Center for Toxicological Research (NCTR) start-up began in the second quarter of FY 2004 and will be completed by October 2004.
  • Data Sources : FY 2001 FDA Workforce Restructuring Plan and PMA/DHHS, Strategic Management of Human Capital

3. Increase the number of Commercial FTE that will be reviewed for competitive sourcing. (19003)

  • Context of Goal: FDA has contracted for many of its commercial requirements and will continue to contract commercial work and identify in-house activities for competitive sourcing. In FY 02, FDA studied the following commercial activities: graphic arts/visual information services, medical/scientific library services, web publishing, and a television studio in the Center for Devices and Radiological Health. In FY 03 FDA studied the following activities: general accounting in the Office of Regulatory Affairs field components, biological technician and physical science technician services, and facilities/real property management services. A functional assessment of clerical functions was completed in late FY 03 to identify clerical functions to be studied in FY 04. This study formally began on 25 February 2004 with a projected completion date of 26 February 2005.
  • Performance: FDA studied 63 commercial FTE's for competitive sourcing in FY 02. The actual performance has changed in FY 02 (from the performance stated in the prior OMB submission) because the initial FY 02 target was based on a formula to complete a percentage of half of our Commercial inventory. At the time the FY 02 goal was written, 72.7 FTE was set as an initial goal because the functional assessment (FA) used to validate the positions was not completed. Now that the FA has been completed, the number of positions that could be competed under A-76 is 63 FTE. There were 63 positions reviewed in FY 02; therefore, we met the FY 02 goal. In FY 03 FDA studied 167 FTE, exceeding the goal set at 145 FTE. FY 04 and FY 05 goals will be exceeded once the clerical support study is completed.
  • Data Sources: FDA Office of Management & Systems, 2001 FAIR Act Inventory

4. Increase the percentage of electronically purchased transactions. (19004)

This goal will no longer be applicable in FY 05.

  • Context of Goal: The percentages are not representative of all purchases, but reflect the percentages of purchases made electronically that were eligible for electronic purchase. The figures represented above also reflect the percentages of transactions and not the percentages of dollar purchases.The FDA expects to exceed these targets in all years.
  • Performance: In FY 04,99 percent of eligible purchases were purchased electronically, exceeding the 91 percent target The Agency conscientiously seeks to use the IMPAC Card instead of a purchase order for buying items under $2,500. By using the IMPAC Card, the Agency lowers the $90.00 overhead cost for each purchase. This has led to the Agency exceeding its goals.
  • Data Sources: FDA Small Purchase System, statements from bank card company

5. Maintain a clean (or unqualified) audit opinion with no material weakness. (19005)

  • Context of Goal: An unqualified audit opinion is a statement by the auditors that an entity's financial statements present fairly, in all material respects, the financial position, its net costs, changes in net position, budgetary resources, and reconciliation of net cost to budgetary obligations for the year ended, in conformity with generally accepted accounting principles. A financial statement material weakness is a significant finding which, in the opinion of the auditors, poses a risk or threat to the internal control systems of an audited entity.

    The table listed below shows additional relevant historical information regarding FDA's prior financial performance and reflects the results of the steps FDA took to get to its current condition. In FY 1997, FDA had 5 reportable conditions, 3 material weaknesses, did not have an unqualified audit opinion, and was not timely provided. Since then, FDA has managed to progressively perform at a higher level.

 

  FY 1997 FY 1998 FY 1999 FY 2000 FY 2001 FY 2002 FY 2003

Timely audit opinion

No

Yes

Yes

Yes

Yes

Yes

Yes

Clean (Unqualified) audit opinion

No

Yes

Yes

Yes

Yes

Yes

Yes

Number of material weaknesses

3

0

0

0

0

0

0

Number of reportable conditions

5

3

3

1

1

1

1

Number of instances of non-compliance with laws and regulations including non-compliance with the Federal Financial Management Improvement Act (FFMIA)

1

1

1

1

1

1

1

  • Performance: FDA received a clean audit opinion on its FY 2004 financial statements but also received a material weakness. The material weakness was disclosed in the area of the payroll processes, which in FY 2004 became a shared function among three separate organizations, the Office of the Secretary (OS), the Program Support Center (PSC), and FDA. FDA will be working with the OS and PSC to resolve the material weakness. In FY 03 FDA received an unqualified opinion on its FY 2003 financial statements with no material weakness in internal controls. All FY 2003 year-end-due dates were met which assisted the Department in meeting the November 15, 2003 due date to OMB. FY 2002 Performance is at 100 percent. Since FY 1997, the performance has steadily improved due to FDA taking many corrective actions, including establishing a branch organized in FY 2000 in the Division of Accounting to prepare financial statements and to interact with the auditors. As a result, FDA went from not having an unqualified opinion with three material weaknesses and five reportable conditions in FY 1997 to having an unqualified opinion with no material weakness and one reportable condition in FY 2001.
  • Data Sources: Fiscal Year 2001 FDA Chief Financial Officer's Annual Report.

6. Maintain percentage of contract dollars allocated to performance based contracts. (19006)

  • Context of Goal: FDA is aligning itself with the OMB goals of awarding 50 percent of eligible contract dollars to firms using performance based contracts by FY05 and will strive to meet this target for FY 06 as well. This will lead to greater accountability of services provided by contractors, and increased efficiency. It should also be noted that not all contract dollars are eligible for this initiative.
  • Performance:In FY 04, FDA exceeded the target of 40% of eligible contract dollars awarded as performance-based contracts. FDA reviews each contract to determine if it is a candidate for performance based contracting. If so, the agency provides the contract's objectives and requests the contractor to provide the method(s) to meet the objective. Once the agency and contractor agree, FDA personnel regularly evaluate the contractor's performance. If necessary, the agency invokes a previously negotiated financial penalty against the contractor for failing to meet the objective(s). This allows the agency and contractor to assure high performance.
  • Data Sources: The agency will rely on the data from the Federal Procurement Data System (FPDS

7. Establish an Agency-wide Enterprise Architecture (EA). (19009)

  • Context of Goal: Clinger-Cohen, the President's Management Agenda, the Department's policy of "One HHS" and PDUFA III are the mandates driving the Agency towards the establishment of an EA. In addition, the EA is a major piece of the Agency's overall strategy in support of the CT program: it will provide the framework on which data can be standardized and integrated to enable real time access of information crucial to the CT effort.
  • Performance: For FY 02, $5 million has been allocated for the development of an Agency-wide Registration System. This will be accomplished through the development of an EA as a first step, with associated CT business processes receiving priority. A contract was awarded and work initiated in FY 02. For FY 03, FDA completed the design and implementation of EA governance. The EA program also documented 90% of the CT and PDUFA business processes. ORA's target architecture was delivered to them. In FY 04, FDA documented all Core Strategic Business Processes. Matured EA Governance process. Integrated EA with Capital Planning & Investment Control (CPIC) process. Completed target architectures for e-submission and ORA.
  • Data Source: EA Strategic Plan and Project Plan; progress reports to HHS, OMB and industry (PDUFA status reports)

8. 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 Federal Information Security Management Act (FISMA). (19010)

  • Context of Goal: FISMA has set requirements for Agency's to identify their key IT assets, assess them for security vulnerability and address any findings. Security is also part of the Department's overall IT Security program. As a result, the Agency is centralizing the security program to ensure security efforts are performed in a uniform and consistent manner, while at the same time leveraging efficiencies (bulk buys, Agency-wide contracts, etc.) that are only possible with Agency-wide scope. FISMA replaced the FY 03 goal of GISRA and more accurately reflects the agencies focus in the area of IT security.
  • Performance: In FY 04, FDA completed the C&A program, including non-CIP assets and implemented the Vulnerability Remediation Program. Additionally, FDA ensured 100% compliance of the FDA IT infrastructure and all major systems for FISMA (formerly known as GISRA) compliance, including appropriate risk mitigation. In FY 03, FDA assessed 100% of the IT infrastructure and major systems in the FDA inventory for FISMA compliance and provided any needed corrections. In addition, a Certification and Accreditation program was initiated, focusing on the FDA's Critical Infrastructure Protection (CIP) inventory; a majority of the inventory will be completed in FY 03 with the remaining done by mid- FY 04. This effort will be further expanded to the non-CIP inventory in FY 04. FDA is using a standardized approach for managing vulnerabilities with the use of Plan of Action and Milestones

    (POA&M). The POA&M allows the agency to prioritize the remediation of vulnerabilities and helps to focus IT resources where needed. Finally, in FY 04, FDA will implement a Vulnerability Remediation Program, consisting of: policies / procedures, tools /utilities,reporting & tracking capabilities, and repeatable processes. In FY 01, the GISRA assessment identified vulnerabilities that were partly the result of inconsistent interpretation and application of security policies across the Agency. In FY 02, FDA assessed OC, NCTR and selected other critical components for GISRA compliance and resolved any access control issues.

  • Data Source: Annual FISMA assessment and report

9. FDA's Implementation of HHS' Unified Financial Management System. (19017)

  • Context of Goal: FDA is working with the Department to establish a unified financial management system. Specifically, the Department plans to utilize two accounting systems: one for the Center for Medicare and Medicaid Services (CMS), formerly the Health Care Financing Administration, and one serving the National Institute of Health (NIH), the Program Support Center (PSC) and its eight servicing OPDIV's, the Center for Disease Control and Prevention (CDC) and FDA. FDA will use the FY 04 increase to complete the preparation to implement the general ledger and accounts payable systems. The goal of the UFMS project is to reduce costs, mitigate security risks, and provide timely and accurate information across DHHS. FDA will acquire and implement a new core financial management system as part of the UFMS project in FY 05. Implementing a new financial system will provide qualitative and quantitative benefits to FDA because it will achieve improved business processes and provide more accurate and timely information to better support FDA's and DHHS' mission.
  • Performance: FDA held a conference room pilot to prototype the design and configuration of UFMS in February 2004. CRP goals included demonstrating that ORACLE software could meet FDA business needs, having the FDA Center representatives actively participate, having FDA staff drive the software, and proving that FDA implementation strategy would meet DHHS needs. Judging by the extremely positive Independent Validation and Verification (IV&V) Draft Report performed by Titan Corporation, the FDA UFMS team successfully accomplished its slated goals and objectives. From that time until mid- December, progress was made to prepare for the interface testing. On December 17, UFMS teams at FDA performed integration testing on the UFMS. In FY 03 major components of data cleanup have been completed. Travel Manager implementation has been complete throughout the Agency in preparation of UFMS.
  • Data Source: The sources are encompassed in the General Ledger & Federal Administrator, the Purchasing & Accounts Payable; and the Accounts Receivable. These sources are being prepared to transition to the Financial Business solutions system.

10. Enhance the Agency Emergency preparedness and response capabilities to be better able respond in the event of a terrorist attack. (19008)

  • Context of Goal: The Office of Crisis Management (OCM) includes the Office of Emergency Operations and the Office of Security Operations. During FY04, OCM and its offices accomplished the following: The Emergency Operations Network will provide seamless access to all FDA offices to enable them to respond quickly to the full range of FDA emergencies. The Network will have the capability to blend FDA emergency expertise into larger emergency teams composed of other Federal, state or local agencies for larger terrorist incidents. The Network will be supported by an information technology infrastructure that will provide decision makers with quick access to emergency documents and information from all pertinent agency sources, as well as provide states with advisory information.

    This goal involves:

    • revising the FDA Crisis Management Plan and the Emergency Response Plan;
    • conducting inter and intra-Agency terrorism and emergency response exercises;
    • updating technology and equipment for the Office of Emergency Operations and the Office of Security Operations;
    • strengthening the coordination for inter and intra-Agency response involving laboratory testing;
    • strengthening collaborations with science and public health, law enforcement,
    • intelligence and international communities;
    • developing the Agency's Emergency Operations Network Incident Management System; and
    • reviewing and revising the FDA hazard specific response plans.

    The initial draft of the FDA's Crisis Management Plan (Version 1.0) was delivered on September 1, 2004. The Crisis Management Plan provides the Agency with a structured methodology that enables the FDA to respond to crisis situations that are beyond the capabilities of existing FDA emergency response resources. The Plan incorporates elements describing the process by which the Agency identifies a crisis, as well as, the role of crisis communication in the FDA's response to a crisis. The FDA's three hazard specific response plans were finalized in FY04 (Radiological Emergency Response Plan-Version 2.0-December 12, 2004, Chemical and Biological Emergency Response Plan-Version 3.0-January 26, 2004, and Bovine Spongiform Encephalopathy Emergency Response Plan-Version 5.0-December 24, 2003). The hazard specific response plans define the different types of emergencies, identify hazard specific protocols, describe the roles of FDA officials, and address interactions between FDA, DHHS, and other governmental entities. In order to enhance the Agency's emergency preparedness and response capabilities the FDA conducted functional exercises of the Radiological Emergency Response Plan (March 17, 2004), as well as, the Chemical and Biological Emergency Response Plan (May 12, 2004). The Bovine Spongiform Encephalopathy Emergency Response Plan was activated during the FDA's response to the first report of Bovine Spongiform Encephalopathy in the United States in December, 2003. FDA continues to strengthen its coordination with other agencies, at all levels of authority, to prepare for and respond to chemical, biological, and radiological emergencies and incidents of terrorism by participating in U.S. and international exercises and working groups.

  • Performance: In FY04, the Emergency Operations Network Incident Management System (EOM IMS) designed, developed, and implemented pilot and production systems. The system was fully certified and accredited in September, 2004, and is used by the FDA Office of Crisis Management/Office of emergency Operations. In FY04, the following emergency response documents were created: Radiological Emergency Response Plan-Version 2.0-December 12, 2004; Chemical and Biological Emergency Response Plan-Version 3.0-January 26, 2004; Bovine Spongiform Encephalopathy Emergency Response Plan-Version 5.0-December 24, 2003; FDA Crisis Management Plan-Version 1.0-September 1, 2004. Coordinated and conducted Agency-wide emergency preparedness and response exercises including the Radiological Functional Exercise in March 2004, and the FDA Chemical and Biological Functional Exercise in May 2004. Recommended the creation of a new workgroup under the Trilateral Cooperation (Canada, U.S., Mexico) for emergency preparedness and response; acted as the first chair of the new workgroup and coordinated and participated in the second trilateral food terrorism exercise in June 2004.
  • Data Sources: Office of Crisis Management/Office of Emergency Operations.

 

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