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FY 2006

PERFORMANCE REPORT
TO CONGRESS
for the
Medical Device User Fee
and Modernization Act
of 2002  

Commissioner's Report

I am pleased to report that the Food and Drug Administration (FDA) continues to succeed in improving the process for the review of device applications and meeting the performance goals established under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).

MDUFMA requires close collaboration with stakeholders and increased communication with applicants. FDA is working to clarify its regulatory requirements and make its decisions more transparent through new guidance, educational materials, and meetings. We continually seek to reduce the burdens associated with device reviews and to improve the efficiency and flexibility of our review processes. These efforts help applicants improve the quality of their submissions, and help FDA provide timelier, better-focused reviews. Our ultimate objective — an objective we share with industry — is to make important new medical devices available to patients and health care providers earlier, while continuing to ensure the quality, safety, and effectiveness of those devices.

MDUFMA will come to an end on October 1, 2007. On that date, FDA's authority to collect and use medical device user fees sunsets, as directed by section 107 of MDUFMA. FDA is committed to working with stakeholders and Congress to ensure timely reauthorization.

I am proud of the significant progress FDA has made in meeting the challenges and responsibilities provided by MDUFMA. I believe the results we have achieved through FY 2006, and the long-term objectives we continue to pursue, clearly demonstrate the value of this important legislation to FDA, to the medical device industry, and, particularly, to patients and health care professionals.

Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs

Executive Summary

MDUFMA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to collect user fees from manufacturers who submit certain applications to market medical devices. In parallel with this authority, MDUFMA requires FDA to pursue a comprehensive set of review performance goals and commitments to improve the timeliness and predictability of medical device reviews and to improve communications between FDA and industry.

FDA has made good progress in implementing MDUFMA and in meeting MDUFMA performance goals. FDA has worked with stakeholders to improve communication and understanding of MDUFMA requirements and to ensure that implementation accomplishes MDUFMA objectives. The performance gains and improved predictability in review processes achieved under MDUFMA are leading to significant benefits to industry, health care professionals, and patients.

FY 2006 Activities

FDA continued to focus on consulting with its stakeholders, developing guidance documents, and designing and building the new review processes required to meet MDUFMA’s challenging performance goals. Among the key activities during FY 2006 were:

• Continued progress in meeting MDUFMA performance goals. FDA is meeting, or is on track to meet, most of the performance goals for FY 2003 through FY 2006 receipt cohorts.
• Guidance to industry. FDA issued six MDUFMA guidance documents during FY 2006; four provided new guidance and two provided updated editions of earlier guidance.
• Regulation of reprocessed single-use devices. FDA issued Federal Register notices specifying when a manufacturer must submit validation data to FDA for a reprocessed single-use device.
• Stakeholder communication and consultation. FDA expanded its outreach to stakeholders, providing additional information through the MDUFMA Internet site at: http://www.fda.gov/cdrh/mdufma, through presentations at industry and professional meetings, and at quarterly meetings with stakeholders. In November 2005, FDA held its third Annual Stakeholder Meeting to report on the implementation of MDUFMA and to hear directly from stakeholders. In May 2006, FDA held a public meeting to discuss implementation of two contingent performance goals for FY 2007; FDA determined it was appropriate to implement both goals.
• Public notification. FDA published 14 Federal Register notices to provide essential information to stakeholders on new guidance documents, proposed rules, regulatory actions, user fees, and other topics, and to request comments and suggestions from stakeholders.

Overall Performance

FDA’s overall performance to date for the FY 2003 through FY 2006 receipt cohorts is consistent with the expectations for the device review program agreed to by FDA. Of the 50 quantifiable performance goals that were in effect for the FY 2003 through FY 2006 cohorts, FDA’s performance to date includes meeting or exceeding 32 goals and not meeting 6 goals. The remaining 12 goals did not have measurable actions as of September 30, 2006.[1]

Table of Contents

Introduction

Overview of MDUFMA

Background

MDUFMA Commitments: Goals and Approaches

MDUFMA Implementation

FY 2006 Activities and Accomplishments

Overview of MDUFMA Performance, FY 2003 through FY 2006

Implementation Plans for FY 2007

Report on FY 2006 MDUFMA Performance

Premarket Approval Applications (PMAs), Panel-Track PMA Supplements, and Premarket Reports

Expedited PMAs

180-day PMA Supplements

510(k) Premarket Notifications

Biologics Licensing Applications (BLAs)

BLA Supplements

Resubmitted BLAs and BLA Efficacy Supplements

Additional MDUFMA Performance Commitments

Appendices

Appendix A: November 14, 2002 , Commitment Letter from HHS Secretary Thompson to Congress

Appendix B: Measuring Performance Under MDUFMA

Appendix C: Summary of MDUFMA's Quantitative Goals

Appendix D: Glossary

Appendix E: Summary of Footnotes

Introduction

". . . prompt approval and clearance of safe and effective devices is critical to the improvement of the public health so that patients may enjoy the benefits of devices to diagnose, treat, and prevent disease . . ."

— Section 101(1) of the Medical Device User Fee and Modernization Act of 2002.

On October 26, 2002, MDUFMA was signed into law. MDUFMA amends the FD&C Act to authorize FDA to collect fees from companies who submit certain applications for marketing of medical devices. In return, MDUFMA requires FDA to pursue a comprehensive set of device review performance goals that are intended to significantly improve the timeliness and predictability of FDA’s review of new devices.[2] These performance goals were developed collaboratively and are defined in the Department of Health and Human Services (HHS) Secretary’s November 14, 2002, letter to Congress.[3] Information about MDUFMA, including the text of the amendments and the performance goals and procedures, can be found on FDA’s web site at: www.fda.gov/oc/mdufma.

MDUFMA requires the Secretary to submit two annual reports to Congress for each fiscal year fees are collected: 1) a performance report due within 60 days of the end of the fiscal year, and 2) a financial report due within 120 days of the end of the fiscal year. This report is FDA’s fourth annual performance report on its progress in achieving MDUFMA performance goals and additional commitments, and covers actions through FY 2006.

On April 1, 2004, MDUFMA was amended and expanded by the Medical Device Technical Corrections Act (MDTCA), P.L. 108-214. MDTCA amends MDUFMA to clarify Congress’s intent and to improve and expand upon some features of MDUFMA. These changes did not affect the performance goals FDA is pursuing under MDUFMA.

On August 1, 2005, the Medical Device User Fee Stabilization Act of 2005 (the "Stabilization Act"), P.L. 109-43 amended provisions of the FD&C Act relating to medical device user fees and device labeling.

Overview of MDUFMA

Background

MDUFMA was signed into law on October 26, 2002, amending the FD&C Act to provide FDA important new responsibilities, resources, and challenges. The goal of MDUFMA is to better serve the public health by providing additional funds to FDA for "the process for the review of devices and the assurance of device safety and effectiveness so that statutorily mandated deadlines may be met." The user fees provided by MDUFMA, and the additional appropriations that go with the new law, will provide the following significant benefits:

• Safe and effective medical devices will reach patients more rapidly.
• Manufacturers will receive timely, high quality reviews with greater consistency.
• Resources will be provided to ensure that devices marketed in the United States continue to meet high standards for safety and effectiveness.

The majority of devices associated with MDUFMA are reviewed by the Center for Devices and Radiological Health (CDRH). However, a number of devices that are critical to ensuring the safety, purity, and potency of biologic products, including assuring the safety of our nation’s supply of blood and human tissue products, are reviewed by the Center for Biologics Evaluation and Research (CBER). Additionally, CBER regulates diagnostic tests for retroviruses, including HIV, as well as devices used in cell and gene therapies. An Intercenter Agreement between CBER and CDRH discusses the types of devices regulated by CBER (available at: www.fda.gov/oc/ombudsman/bio-dev.htm ).

MDUFMA Commitments: Goals and Approaches

This report is concerned primarily with the performance goals that are an integral part of MDUFMA. FDA has prepared a summary of MDUFMA, including information on topics not covered by this report; see www.fda.gov/cdrh/mdufma/mdufmasummary.pdf. FDA also prepares an annual financial report that provides information on review fee revenues and expenses and compliance with MDUFMA requirements concerning the collection and use of those fees; the current and past reports are available at: www.fda.gov/oc/mdufma.

MDUFMA has three particularly significant provisions related to FDA performance:

1. User fees for premarket reviews, including premarket approval applications (PMAs), product development protocols, premarket reports, biologics licensing applications (BLAs), certain supplements, and 510(k) premarket notifications. The revenues from these fees, and from additional appropriations, allow FDA to pursue a set of performance goals that are intended to provide patients earlier access to safe and effective technology, and provide more interactive and rapid review to the medical device industry. An applicant that qualifies as a "small business" (gross receipts or sales of $100 million or less) may pay a reduced fee, and if the applicant has gross receipts or sales of $30 million or less, it may obtain a waiver of the fee for its first premarket application (PMA, BLA, product development protocol, or premarket report). The payment of a premarket review fee is not related to FDA’s final decision on a submission.
2. Establishment inspections may be conducted by accredited persons (third parties), under carefully prescribed conditions.
3. New regulatory requirements for reprocessed single-use devices, including provisions requiring the submission of additional data on devices now being reprocessed, and a new category of premarket submission, the premarket report.

MDUFMA made several other significant changes, including:

• The existing third-party 510(k) review program is continued through FY 2006.
• The review of combination products (products that combine elements of devices, drugs, or biologics) are coordinated by the Office of Combination Products in the Office of the Commissioner
• FDA may require electronic registration of device establishments, when feasible
• Manufacturers may provide electronic labeling for prescription devices used in health care facilities or by a health care professional
• The sunset provision, which addresses how FDA is to determine the intended use of a device, is revoked.[4] The effect is to make the requirement permanent
• The law now explicitly provides for modular review of PMAs.

Phased-In Performance Goals

Performance goals increased in number, complexity, and difficulty beginning in FY 2005. Few objectively-measurable goals were applied during FY 2003 and FY 2004, allowing FDA time to hire staff, build infrastructure, provide guidance to industry, and take other actions to implement the new law. More goals went into effect in FY 2006 and will again in FY 2007, with the goals becoming more demanding each year. FDA must continually improve its processes and performance if it is to meet these goals (see Appendix C for an overview of MDUFMA’s objectively-measurable performance goals).

MDUFMA Implementation

In addition to authorizing FDA to collect user fees for medical device applications, MDUFMA established review performance goals for FDA. These goals are intended to achieve progressive, year-by-year, improvements in review processes for medical devices. The performance goals recognized that FDA would need a 2-year start-up period (FY 2003 through FY 2004) to hire and train new staff and rebuild review program infrastructures before it would be possible to begin to make substantial progress in improving overall review performance. Consequently, most substantive review performance goals went into effect in FY 2005. User fees, coupled with additional appropriations from Congress, will help FDA more efficiently and more quickly make safe and effective medical devices available to the public.

FY 2006 Activities and Accomplishments

FDA made steady progress in implementing MDUFMA in FY 2006. FDA continued to focus on consulting with its stakeholders, developing guidance documents, and building the new review processes required to meet MDUFMA’s progressively challenging performance goals. Among the key activities and accomplishments during FY 2006 were:

• Steady progress in meeting MDUFMA performance goals. FDA is meeting, or is on track to meet, most of the performance goals for FY 2003 through FY 2006 receipt cohorts.
• Guidance documents. FDA issued six MDUFMA guidance documents during FY 2006; four provided new guidance and two provided updated editions of earlier guidance.
1. Validation Data in Premarket Notification Submissions [510(k)s] for Reprocessed Single-Use Medical Devices (revised edition, September 2006); http://www.fda.gov/cdrh/ode/guidance/1216.pdf.
2. Early Development Considerations for Innovative Combination Products (September 2006); http://www.fda.gov/oc/combination/innovative.html.
3. FY 2007 MDUFMA Small Business Qualification Worksheet and Certification (August 2006; replaces guidance for FY 2006); http://www.fda.gov/cdrh/mdufma/guidance/2006.pdf.
4. Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended — Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices (May 2006; final guidance, replaces prior draft guidance); http://www.fda.gov/cdrh/comp/guidance/1217.html.
5. The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations (June 2006); http://www.fda.gov/cdrh/comp/guidance/1566.pdf.
6. The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program (June 2006); http://www.fda.gov/cdrh/comp/guidance/1602.pdf.
• Stakeholder communications. FDA held an annual stakeholder meeting on November 17, 2005, and a meeting on May 22, 2006, to discuss the possible implementation of the two contingent review performance goals for FY 2007. With stakeholder input, FDA decided to implement the two review performance goals for FY 2007: 1) 50 percent of the premarket approval applications received in FY 2007 will have an FDA decision in 180 days5] and 2) 80 percent of the premarket notifications will have an FDA decision in 90 days.
• Public notification. FDA issued 14 Federal Register notices in FY 2006.
• Reports to Congress issued in FY 2006. FDA issued to Congress the FY 2005 MDUFMA Performance Report, the FY 2005 MDUFMA Financial Report, and the FY 2005 Office of Combination Products Report

Overview of MDUFMA Performance, FY 2003 through FY 2006

A preliminary performance assessment from FY 2003 through FY 2006 indicates that FDA is meeting or exceeding most of the MDUFMA performance goals for submissions subject to MDUFMA goals (see tables below). This assessment is based on data through September 30, 2006, and will be updated for each open cohort on an annual basis.[6] [7]

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Implementation Plans for FY 2007

During FY 2007, FDA will work to meet increased performance expectations, and to position the device review program to extend the performance improvements achieved under MDUFMA into FY 2008 and later years. The FY 2007 efforts for FDA will focus on:

• Increased performance expectations.FDA will implement a new goal for FY 2007 (50 percent of PMAs/panel-track PMA supplements received in FY 2007 are to have an "FDA decision" within 180 days).5 Twenty-five goals will have higher performance levels for FY 2007. Two goals remain unchanged from FY 2006.
• "Follow-on" licensed devices. FDA will determine whether it is feasible to identify a category of "follow-on" licensed devices. If it is feasible to identify "follow-on" licensed devices, FDA will then determine whether specific performance goals appear to be appropriate for the review of such devices. If specific performance goals are appropriate, FDA will work with stakeholders to define and implement those goals.
• MDUFMA reauthorization. FDA will consult with stakeholders on reauthorization of MDUFMA (the existing authority sunsets October 1, 2007), and will hold a public meeting to discuss recommendations for Congressional consideration. Reauthorization is critical to continued success of FDA's medical device review program.

Report on FY 2006 MDUFMA Performance

This section presents FDA's preliminary performance on MDUFMA performance goals and commitments for FY 2006. Additionally, performance information between FY 2003 and FY 2005 presented in FDA’s previous MDUFMA performance reports has been updated to include additional actions FDA completed during FY 2006. While performance is presented for all goals from FY 2003 through FY 2006, performance tables list "no goal" in fiscal years where no MDUFMA performance goal was in effect. All performance data in this section reflects FDA actions through September 30, 2006.

Performance goals. MDUFMA requires that FDA meet the following types of performance goals:

• Cycle goals. A cycle goal is a goal on a specified action that precedes a final action on the submission.

  Example : One of the goals for Expedited PMAs in the FY 2005 receipt cohort calls for FDA to issue 70 percent of "first action major deficiency letters" within 120 days. A major deficiency letter is not a final action; the applicant can continue the review by preparing and submitting an amendment that addresses the deficiencies identified in FDA's major deficiency letter.

• Decision goals.A decision goal, on the other hand, is a goal on a final action that ends the review process.

  Example : One of the goals for 510(k) premarket notifications in the FY 2005 receipt cohort calls for FDA to make 70 percent of "FDA decisions" within 90 days. FDA decisions for 510(k)s are "substantially equivalent" (SE) and "not substantially equivalent" (NSE) decisions. An SE or NSE decision ends the 510(k) review process.

Additional commitments. In addition to the performance goals, MDUFMA holds FDA to several commitments related to the medical device review process. These include, for example, programs and activities related to the application of user fee revenues, guidance development for the modular PMA review program,[8] and examination of FDA’s bundling policy. [9]

Measuring performance.[10] Progress on MDUFMA performance goals and commitments is measured in different ways, based on the type of goal or commitment. The following types of measures are used to capture FDA’s progress on meeting MDUFMA performance goals and commitments:

• Quantitative measures. MDUFMA performance goals (cycle and decision goals) are quantifiable; that is, progress can be measured and described primarily through standard statistics (for example, number of submissions, mean review time, median review time, and percent meeting a review time standard).
• Descriptive measures. Alternatively, some MDUFMA commitments are more descriptive in nature. For example, progress is reported through narrative accounts outlining specific actions taken, in addition to any results attributed to those actions.

Receipt cohort. Review performance statistics are based on a receipt cohort. This methodology calculates performance statistics for the fiscal year submissions were received, regardless of when FDA acted on the submissions. A result of this approach is that the statistics shown for a particular fiscal year may change from one report to the next. This is because as time passes, FDA continues to complete work on submissions within a fiscal year cohort. As more submissions are completed, the statistics for that fiscal year of receipt must be adjusted to reflect the new completions. Until all submissions in a cohort receive a final decision, only a preliminary performance assessment can be provided for that cohort. The word "cohort," as used in this section, refers to a MDUFMA fiscal year cohort.

Premarket Approval Applications (PMAs), Panel-track PMA Supplements, and Premarket Reports

Goals

The table below summarizes the annual review time goals for PMAs, panel-track PMA supplements, and premarket reports. In FY 2003, the cycle goal of reviewing 90 percent of amendments containing a complete response to an "approvable" letter within 30 days became effective. Four additional cycle goals became effective in FY 2005 with the performance levels increasing incrementally through FY 2007. The decision goal became effective in FY 2006 with the performance levels increasing from 80 percent in FY 2006 to 90 percent in FY 2007.

Workload

The total number of PMA and panel-track PMA supplements submitted in FY 2006 decreased, returning to FY 2003 and FY 2004 levels.[11]

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Premarket Approval Applications (PMAs), Panel-track PMA Supplements, and Premarket Reports

Performance

Decisions. FDA made decisions on over one-third (19 of 51) of the FY 2006 cohort. Preliminary numbers for the FY 2006 cohort indicate FDA is exceeding the MDUFMA performance goal for making an "FDA decision" (see table below).

First Action Letters. FDA issued first action letters for all but one (57 of 58) of the FY 2005 cohorts and over four-fifths (42 of 51) of the FY 2006 cohorts. Preliminary numbers for the FY 2005 and FY 2006 cohorts indicate FDA is exceeding the MDUFMA performance goals for issuing a "major deficiency" letter as the first action and for issuing all other first action letters (see table below).

Performance

Second or Later Actions. Preliminary numbers for the FY 2005 cohort indicate FDA is not meeting the MDUFMA performance goal for issuing a "major deficiency" letter as the second or later action (see table below). Preliminary numbers for the FY 2006 cohort indicate that FDA is exceeding the MDUFMA performance goal.

Amendments. FDA reviewed and acted on all amendments received for the FY 2003 through FY 2006 cohorts. Preliminary numbers for the FY 2005 and FY 2006 cohorts indicate FDA is exceeding the MDUFMA performance goal for acting on an amendment containing a complete response to a "major deficiency" or "not approvable" letter (see table below). Preliminary numbers for the FY 2003 through FY 2005 cohorts indicate FDA is not meeting the MDUFMA performance goal for acting on an amendment containing a complete response to an "approvable" letter.

Expedited PMAs

Goals

The table below summarizes the annual review time goals for expedited PMAs. In FY 2003, the cycle goal of reviewing 90 percent of amendments containing a complete response to an approvable" letter within 30 days became effective. The decision goal and four additional cycle goals became effective in FY 2005 with the performance levels increasing incrementally from 70 percent in FY 2005 to 90 percent in FY 2007.

Workload

The total number of expedited PMA submissions received in FY 2006 continued to decrease from the FY 2004 high of 14, returning close to the FY 2003 level.

D

Performance

Decisions. FDA made decisions on half (3 of 6) of the FY 2005 cohort, and no actions were completed for the FY 2006 cohort. Preliminary numbers for the FY 2005 cohort indicate FDA is not meeting the MDUFMA performance goal for making an "FDA decision" (see table below).

First Action Letters. FDA issued first action letters for all of the FY 2005 cohorts and one of two for the FY 2006 cohorts. Final numbers for the FY 2005 cohorts indicate FDA exceeded the MDUFMA performance goals for issuing a "major deficiency" letter as the first action and for issuing all other first action letters (see table below). Preliminary numbers for the FY 2006 cohort indicate FDA is exceeding the MDUFMA performance goal for issuing all other first action letters.

Perfomance

Second or Later Action Letters. Preliminary numbers for the FY 2005 cohort indicate FDA is exceeding the MDUFMA performance goal for issuing a "major deficiency" letter as the second or later action (see table below).

Amendments. FDA reviewed and acted on all amendments received for the FY 2003 through FY 2006 cohorts. Preliminary numbers for the FY 2005 cohort indicate FDA is exceeding the MDUFMA performance goal for acting on an amendment containing a complete response to a "major deficiency" or "not approvable" letter (see table below). Final numbers for the FY 2003 cohort indicate FDA exceeded the MDUFMA performance goal for acting on one amendment containing a complete response to an "approvable" letter. Preliminary numbers for the FY 2004 cohort indicate FDA is not meeting the MDUFMA performance goal.

180-Day PMA Supplements

Goals

The table below summarizes the annual review time goals for 180-day PMA supplements. The decision goal and three cycle goals became effective in FY 2005 with the performance levels increasing from 80 percent in FY 2005 to 90 percent in FY 2007.

Workload

The total number of 180-day PMA supplements received in FY 2006 increased compared to the FY 2004 and FY 2005 levels, but remained less than FY 2003.

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180-day PMA Supplements

Performance

Decisions. FDA made decisions on all of the FY 2005 cohort and almost three-fourths (95 of 131) of the FY 2006 cohort. Final numbers for the FY 2005 cohort indicate FDA exceeded the MDUFMA performance goal for making an "FDA decision" (see table below). Preliminary numbers for the FY 2006 cohort indicate FDA is exceeding the MDUFMA performance goal.

First Action Letters. FDA issued first action letters for all of the FY 2005 cohort and almost three-fourths (97 of 131) of the FY 2006 cohort. Final numbers for the FY 2005 cohorts indicate FDA exceeded the MDUFMA performance goals for issuing a "not approvable" letter and for issuing all other first actions (see table below). Preliminary numbers for the FY 2006 cohorts indicate FDA is meeting or exceeding the MDUFMA performance goals.

180-Day PMA Supplements

Performance

Amendments. FDA reviewed and acted on all amendments received for the FY 2003 through FY 2006 cohorts. Preliminary numbers for the FY 2005 and FY 2006 cohorts indicate FDA is exceeding the MDUFMA performance goal for acting on an amendment containing a complete response to a "not approvable" letter (see table below).

510(k) Premarket Notifications

Goals

The table below summarizes the annual review time goals for 510(k) premarket notifications. The decision goal and two cycle goals became effective in FY 2005. The performance level for the decision goal remains constant at 75 percent for FY 2005 and FY 2006 and increases to 80 percent in FY 2007. The performance levels for the two cycle goals increase incrementally from 70 percent in FY 2005 to 90 percent in FY 2007.

Workload

The total number of 510(k) submissions received in FY 2006 increased compared to FY 2004 and FY 2005 levels. The MDUFMA cohort portion of 510(k) submissions increased for 3 straight years and represented over 95 percent of total submissions in FY 2006 (see graph to the right and table below).[18]

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510(k) Premarket Notifications

510(k) Premarket Notifications

Performance

Decisions. FDA made decisions on almost all (3,376 of 3,415) of the FY 2005 cohort and two-thirds (2,503 of 3,732) of the FY 2006 cohort. Preliminary numbers for the FY 2005 and FY 2006 cohorts indicate FDA is exceeding the MDUFMA performance goal for making a "substantially equivalent" or "not substantially equivalent" decision (see table below).

First Action Letters. FDA issued first action letters for over half (1,847 of 3,415) of the FY 2005 cohort and almost half (1,814 of 3,732) of the FY 2006 cohort. Preliminary numbers for the FY 2005 and FY 2006 cohorts indicate FDA is exceeding the MDUFMA performance goal for issuing an "additional information" letter as a first action (see table below).

Performance

Second or Later Action Letters. Preliminary numbers for the FY 2005 and FY 2006 cohorts indicate FDA is exceeding the MDUFMA performance goal for issuing any second or later action letter (see table below).

Biologics Licensing Applications (BLAs)

Goals

The table below summarizes two new annual review time goals for FY 2006 MDUFMA performance levels for standard and priority original BLA submissions. Performance levels increase from 75 percent in FY 2006 to 90 percent in FY 2007.

Workload

The number of standard BLAs submitted almost tripled in FY 2006 when compared to FY 2005, reaching a 4-year high (see graph to the right and table below). No priority BLAs were received from FY 2003 through FY 2006.

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Original BLAs

Performance

Complete Action Letters. FDA has not completed review and action on any of the standard BLA submissions (issue "complete action" letter) received for the FY 2006 cohort (see table below). With standard BLA submissions still pending and not overdue as of September 30, 2006, it is too early to make a final performance determination for the FY 2006 cohort.