FY 2008 ADUFA Performance Report

Printable version

Table of Contents

Commissioner’s Report

Executive Summary

Overview of ADUFA

Progressive Goal Setting Over 5 Years

FY 2008 Activities and Accomplishments

ADUFA Reauthorization

Report on Final FY 2007 and Preliminary FY 2008 ADUFA Cohort Performance

Review Performance At-A-Glance for FY 2007 and FY 2008NADAs and Reactivations  

Supplemental NADAs and Reactivations

INAD Submissions

Abbreviated New Animal Drug Applications

Appendices

Appendix A:  Department of Health and Human Services (HHS) Secretary’s Commitment Letter to Congress

Appendix B:  Summary of the ADUFA Performance Goals

Commissioner’s Report

I am pleased to present the Food and Drug Administration’s (FDA’s) Fiscal Year (FY) 2008 Performance Report to Congress for the Animal Drug User Fee Act (ADUFA) of 2003. This report presents FDA’s accomplishments for FY 2008, the fifth year operating under ADUFA, and also updates and finalizes FY 2007 performance data. It is my pleasure to report that FDA exceeded each ADUFA performance goal for FY 2007 and is meeting review time goals for all submissions reviewed and acted on in FY 2008.

FDA’s fifth year under ADUFA has been highly productive and successful. FDA has exceeded all of the review performance goals established under ADUFA. This has been accomplished by hiring and training additional FDA staff, and developing and disseminating guidance, policy, and procedural documents. 

FDA is committed to improving the efficiency, quality, and predictability of the new animal drug review process. With the reauthorization of ADUFA, we are dedicated to exploring new approaches and technologies that offer high quality and cost-effective improvements in FDA’s review of new animal drug applications (NADAs) and submissions. FDA plans to:

• • Provide an “end-review amendment” process that enables FDA reviewers to work with the drug sponsor to amend pending submissions and significantly reduce the number of submission review cycles.
  • Establish an electronic submission tool that allows industry to submit drug applications electronically.

FDA looks forward to the continued success and significant improvements in the animal drug review process made achievable by ADUFA.

                                                                                 Frank M. Torti, M.D., MPH

                   Acting Commissioner of Food and Drugs

Executive Summary

On November 18, 2003, the President signed ADUFA into law. ADUFA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to collect user fees from new animal drug sponsors. Under ADUFA, FDA agreed to pursue a comprehensive set of review performance goals to improve the timeliness and predictability of the review of NADAs and investigational new animal drug (INAD) submissions. This report updates and finalizes FY 2007 accomplishments and describes FDA’s achievements toward meeting the FY 2008 performance goals.

FDA continues to meet or exceed expectations established by ADUFA. Among the key activities and accomplishments during FY 2008 were:

• • FDA completed all reviews of FY 2007 submissions and exceeded all ADUFA performance goals for FY 2007.
  • Preliminary performance data on FY 2008 submissions shows that FDA meeting review time goals for all submissions reviewed and acted on in FY 2008.
  • FDA published an updated Guidance Number 170: Guidance for Industry - Animal Drug User Fees and Fee Waivers and Reductions. This guidance updates the definitions for “minor use” and “minor species.”
  • FDA also drafted the following guidance documents: Draft Guidance Number 179: Guidance for Industry - Use of Animal Clones and Clone Progeny for Human Food and Animal Feed and Draft Guidance Number 187: Draft Guidance for Industry - Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs.

Overview of ADUFA

ADUFA was signed into law on November 18, 2003, amending the FD&C Act and providing FDA with important new responsibilities, resources, and challenges. The goal of ADUFA is to better serve animal health and public health by providing additional funds to augment FDA resources devoted to “the process for review of new animal drug applications.”

ADUFA authorizes FDA to collect user fees to support the review of new animal drugs in four categories: applications, establishments, products, and sponsors. Under ADUFA, FDA agreed to meet review performance goals for certain submissions over 5 years. These goals strive to expedite the review of new animal drug applications (NADAs), supplemental NADAs, and investigational new animal drug (INAD) submissions. This program is similar to the Prescription Drug User Fee Act (PDUFA) program for human drugs that has been in place for 16 years. The expectation is that ADUFA, like PDUFA, will help FDA expedite and improve its review of applications for new animal drugs so that safe and effective new products will be available more quickly. The guidelines and definitions below apply to FDA’s implementation of ADUFA.

Review and Act on Applications and Submissions. The term "review and act on" is understood to mean the issuance of a complete action letter after the complete review of an animal drug application, supplemental animal drug application, or investigational animal drug submission which either (1) approves an animal drug application or supplemental application, or notifies a sponsor that an INAD submission is complete, or (2) sets forth in detail the specific deficiencies in such animal drug application, supplemental animal drug application, or investigational animal drug submission and, where appropriate, the actions necessary to place such an application, supplemental application, or submission in condition for approval.

Refuse to File Applications and Refuse to Review Submissions. Within 30 days of submission, FDA shall “refuse to file” an animal drug application, supplemental animal drug application, or their reactivation, which is determined to be insufficient on its face or otherwise of unacceptable quality for review upon initial inspection per Title 21 of the Code of Federal Regulations (CFR) section 514.110. Thus, FDA will refuse to file an application containing numbers or types of errors, or flaws, in the development plan, sufficient to cause the quality of the entire submission to be questioned to the extent that FDA cannot reasonably review it. Within 60 days of submission, FDA will refuse to review an INAD submission which is determined to be insufficient on its face or otherwise of unacceptable quality upon initial inspection using criteria and procedures similar to those found in 21 CFR 514.110. A decision to refuse to file an application or to refuse to review a submission as described above will result in the application or submission being excluded from the cohort upon which the relevant user fee goal is based. FDA records the numbers and types of these exclusions and has included them in this annual performance report.

ADUFA requires that the Secretary submit two annual reports to Congress for each fiscal year during which fees are collected: 1) a performance report due within 60 days of the end of the fiscal year, and 2) a financial report within 120 days of the end of the fiscal year. This report is FDA’s fifth annual performance report, and updates and finalizes FY 2007 cohort data. FDA’s continuing progress in meeting quantifiable ADUFA review goals for FY 2008 is also summarized in this report. Information about ADUFA, including the text of the Department of Health and Human Services (HHS) Secretary’s November 13, 2003, commitment letter to Congress, is located in Appendix A and can also be found at: http://www.fda.gov/oc/adufa .

Progressive Goal Setting Over 5 Years

ADUFA established review performance goals for FDA, phased in over a 5‑year period. These performance goals ran from FY 2004 through FY 2008 and were intended to achieve progressive, yearly improvements in the process for review of NADAs. FDA agreed to review and act on submissions within shorter periods of time each new year. With the fifth year of ADUFA ending on September 30, 2008, FDA agreed to review and act on 90 percent of the following submission types within the specified times:

• • NADAs and reactivations of such applications within 180 days after submission date.
  • Non-manufacturing supplemental NADAs (that is, supplemental NADAs for which safety or effectiveness data are required) and reactivations of such supplemental applications within 180 days after submission date.
  • Manufacturing supplemental NADAs and reactivations of such supplemental applications within 120 days after submission date.
  • INAD study submissions within 180 days after submission date.
  • INAD submissions consisting of protocols that FDA and the sponsor consider essential to making the decision to approve or disapprove an animal drug application or supplemental animal drug application, without substantial data, within 50 days after submission date.
  • Administrative NADAs submitted after all scientific decisions have been made in the investigational animal drug process (that is, prior to submission of the NADA) within 60 days after submission date.

While the performance goal of reviewing 90 percent of submissions within specified times remained constant over the 5-year ADUFA period, the specified time frames incrementally decreased over this period for all submission types. The FY 2008 review time goals were the most challenging and difficult for FDA to meet, as review time goals decreased to the shortest number of review days for this 5-year period. The 5-year progression of these goals is presented in Appendix B.  

FY 2008 Activities and Accomplishments

FDA continued to exceed expectations in implementing ADUFA. Key activities and accomplishments during FY 2007 and FY 2008 included:  

• • FY 2007 ADUFA Cohort Performance. All applications and submissions received in FY 2007 were reviewed and acted on, and FDA exceeded each of the FY 2007 ADUFA performance goals.
  • FY 2008 ADUFA Cohort Performance. Preliminary performance results indicate that FDA met all of the review time goals defined under ADUFA for applications and submissions that were acted on for the FY 2008 cohort. With additional FY 2008 submissions still pending action as of September 30, 2008, FDA will update FY 2008 performance in the FY 2009 report to reflect these pending actions.
  • Guidance Development. FDA developed several guidance documents during FY 2008 including:
    • Guidance Number 170: Guidance for Industry - Animal Drug User Fees and Fee Waivers and Reductions. This final guidance revised the Minor Use or Minor Species (MUMS) waiver, updating the referencing definitions of “minor use” and “minor species” as they appear in the Act as a result of the passage of the MUMS Animal Health Act of 2004.
    • Draft Guidance Number 179: Guidance for Industry - Use of Animal Clones and Clone Progeny for Human Food and Animal Feed. This draft guidance describes FDA’s recommendations regarding the introduction of edible products from animal clones and their progeny into the food and feed supply.
    • Draft Guidance Number 187: Draft Guidance for Industry - Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs. This draft guidance clarifies requirements and recommendations for producers and developers of genetically engineered animals and their products.

These guidance documents and others are available on the Center for Veterinary Medicine (CVM) homepage on FDA’s Web site at: http://www.fda.gov/cvm/Guidance/published.htm.

ADUFA Reauthorization

ADUFA was set to expire on September 30, 2008. On August 14, 2008, the Animal Drug User Fee Amendments of 2008 was signed into law. The new amendments extend ADUFA through 2013. 

The reauthorization of ADUFA continues the FY 2008 review timeframes for key submissions. It also provides for the following enhancements to the program to reduce review cycles and improve communications during reviews:

• • An “end-review amendment” process that enables FDA reviewers to work with the drug sponsor to amend pending submissions to achieve a complete review decision. The intent of this action is to significantly reduce the number of submission review cycles.
  • Develop an electronic submission tool that allows industry to submit drug applications electronically and provide reviewers with the ability to evaluate applications online; participate with industry in 10 public workshops by the end of FY 2013 on mutually agreed-upon topics; and improve communications by improving the timeliness and predictability of foreign pre-approval inspections.

Report on Final FY 2007 and Preliminary FY 2008 ADUFA Cohort Performance  

This report updates and finalizes FY 2007 review performance and describes FDA's review performance in FY 2008 for all the ADUFA performance goals and commitments completed as of September 30, 2008. The following information refers to FDA performance presented in this report.

• • All FDA review performance statistics are based on a fiscal year receipt cohort. This methodology calculates performance statistics for submissions for the fiscal year FDA received them, regardless of when FDA ultimately acted on or approved the submissions. A result of this approach is that the statistics shown for a particular year may change from one report to the next. This is because, as time passes, FDA completes work on more and more submissions in a receipt cohort. As more submissions are completed, the statistics for that year of receipt must be adjusted to reflect the new completions. Until all submissions in a cohort are completed, only a preliminary performance assessment can be provided for that cohort. Performance information in this report is based on actions completed as of September 30, 2008.
  • FDA reviewed and acted on all applications and submissions received during FY 2007 and final performance with respect to achieving goals can now be reported.
  • Only a preliminary performance assessment is possible on applications and submissions received and acted on during FY 2008. For submission categories with a longer review goal, for example, 180 days, early review performance data is limited. For those submissions with a review goal that is shorter, for example, 50 days, performance for submissions received early in the fiscal year may provide an early indicator of review performance.
  • MUMS conditional approvals are not counted as NADAs and, therefore, review performance on them is not presented in this report. The goal of MUMS is to encourage development of products for treatment of minor species or for treatment of animal diseases and conditions of major species that occur infrequently or in limited geographic areas.
  • The count for FY 2008 includes all submissions received in the last month of    FY 2008 as filed. FDA makes a filing decision within 30 days of receiving an original application. FDA calculates ADUFA review times, however, from the original receipt of the filed application.
  • Applications and submissions that FDA identified as refused to file or withdrawn, and reviews that were stopped at the request of the sponsor (applies to INAD submissions only) are not included in the statistics used to measure performance. These applications and submissions are noted, however, in the relevant workload narratives and footnotes for performance goals.

Review Performance At-A-Glance for FY 2007 and FY 2008

The tables below summarize FDA’s review performance for FY 2007 and FY 2008 submissions.

 Final review performance can now be provided for FY 2007. FDA exceeded performance for all FY 2007 ADUFA review performance goals.

Preliminary performance is presented for FY 2008 as reviews were pending and still within the review time goal, as of September 30, 2008. Preliminary performance results indicate that FDA is meeting all of the review time goals for FY 2008. 

Additional information is provided on individual goals in this section.

Appendix A: Department of Health and Human Services 

(HHS) Secretary’s Commitment Letter to Congress

On November 13, 2003, HHS Secretary Tommy G. Thompson sent identical performance goal letters to the following four members of Congress:

The Honorable Judd Gregg

Chairman

Committee on Health, Education, Labor and Pensions

United States Senate

The Honorable Edward Kennedy

Ranking Minority Member

Committee on Health, Education, Labor and Pensions

United States Senate

The Honorable W. J. (Billy) Tauzin

Chairman

Committee on Energy and Commerce

U.S. House of Representatives

The Honorable John Dingell

Ranking Minority Member

Committee on Energy and Commerce

U.S. House of Representatives

This appendix provides one copy of the four identical letters and a summary of the goals and procedures of CVM as agreed to under the "Animal Drug User Fee Act of 2003."

 Animal Drug User Fee Act Performance

 Goals and Procedures

The goals and procedures of the FDA Center for Veterinary Medicine (CVM) as agreed to under the “Animal Drug User Fee Act of 2003” are summarized as follows:

Five-Year Goals (to be implemented by September 30, 2008)

1. Review and act on 90 percent of complete animal drug applications (NADAs) and reactivations of such applications within 180 days after submission date.

2. Review and act on 90 percent of non-manufacturing supplemental animal drug applications (i.e. supplemental animal drug applications for which safety or effectiveness data are required) and reactivations of such supplemental applications within 180 days after submission date.

3. Review and act on 90 percent of manufacturing supplemental animal drug applications and reactivations of such supplemental applications within 120 days after submissions date.

4. Review and act on 90 percent of investigational animal drug study submissions within 180 days after submission date.

5. Review and act on 90 percent of investigational animal drug submissions consisting of protocols, that the Agency and the sponsor consider to be an essential part of the basis for making the decision to approve or not approve an animal drug application or supplemental animal drug applications, without substantial data within 50 days after submission date.

6. Review and act on 90 percent of administrative animal drug applications (NADAs submitted after all scientific decisions have been made in the investigational animal drug process, i.e., prior to the submission of the NADA) within 60 days after the submission date.

The term "review and act on" is understood to mean the issuance of a complete action letter after the complete review of an animal drug application, supplemental animal drug application, or investigational drug submission which either (1) approves an animal drug application or supplemental application or notifies a sponsor that an investigational new animal drug submission is complete or (2) sets forth in detail the specific deficiencies in such animal drug application, supplemental animal drug application, or investigational animal drug submission and, where appropriate, the actions necessary to place such an application, supplemental application, or submission in condition for approval. Within 30 days of submission, FDA shall refuse to file an animal drug application, supplemental animal drug application, or their reactivation, which is determined to be insufficient on its face or otherwise of unacceptable quality for review upon initial inspection as per 21 CFR 514.110. Thus, the Agency will refuse to file an application containing numbers or types of errors, or flaws in the development plan, sufficient to cause the quality of the entire submission to be questioned to the extent that it cannot reasonably be reviewed. Within 60 days of submission, FDA will refuse to review an investigational animal drug submission which is determined to be insufficient on its face or otherwise of unacceptable quality upon initial inspection using criteria and procedures similar to those found in 21 CFR 514.110. A decision to refuse to file an application or to refuse to review a submission as described above will result in the application or submission not being entered into the cohort upon which the relevant user fee goal is based. The Agency will keep a record of the numbers and types of such refusals and include them in its annual performance report.

FDA may request minor amendments to animal drug applications, supplemental animal drug applications, and investigational animal drug submissions. At its discretion, the Agency may extend an internal due date (but not a user fee goal) to allow for the complete review of an application or submission for which a minor amendment is requested. If a pending application is amended with significant changes, the amended application may be considered resubmitted, thereby effectively resetting the clock to the date FDA received the amendment. The Agency intends to establish the same policy for investigational animal drug submissions.

Sponsors are not required to submit study protocols for review. However, for each voluntarily submitted protocol for a study that the Agency and the sponsor considered to be an essential part of the basis for making the decision to approve or not approve an animal drug application or supplemental animal drug application, the Agency will issue an acknowledgment letter providing comments resulting from a complete review of the protocol. The acknowledgement letter will be as detailed as possible considering the quality and level of detail of the protocol submission; will include a succinct assessment of the protocol; and will state whether the Agency agrees, disagrees, or lacks sufficient information to reach a decision that the protocol design, execution plans and data analyses are adequate to achieve the objectives of the study. If the Agency determines that a protocol is acceptable, this represents an agreement that the data generated by the protocol can be used to support a safety or effectiveness decision regarding the subject animal drug. The fundamental agreement is that having agreed to the design, execution, or analyses proposed in protocols reviewed under this process, the Agency will not later alter its perspectives on the issues of design, execution or analyses unless public or animal health concerns unrecognized at the time of protocol assessment under this process are evident.

Interim Backlog Goals

1. Review and act on pending animal drug applications, supplemental animal drug applications, and investigational animal drug submissions within 24 months of initiation of user fee payments.

Additional Interim Goals

1. Fifty percent of FDA incremental review staff recruited and on-board by first quarter of FY 2006. Total staff increment on-board by end of FY 2008.

2. FDA will review all submissions in accordance with procedures for working within a queue. An application/submission that is not reviewed within the applicable interim Application/Submission Goal time frame (noted below) will be reviewed with the highest possible priority among those pending.

Interim Application/Submission Goals

FY 04 Review and Act on 90 percent of:

• • NADAs and reactivations of such applications received during FY 2004 are reviewed within 295 days.
  • Non-manufacturing supplement animal drug application and reactivations of such supplemental Manufacturing supplemental animal drug applications and reactivations of such supplemental applications received during FY 2004 are reviewed within 320 days.
  • Manufacturing supplemental animal drug applications and reactivations of such supplemental applications received applications received during FY 2004 are reviewed within 225 days.
  • Investigational animal drug study submissions received during FY 2004 are reviewed within 320 days.
  • Investigational animal drug submissions consisting of protocols, that the Agency and the sponsor consider to be an essential part of the basis for making the decision to approve or not approve an animal drug application or supplemental animal drug application, without substantial data received during FY 2004 are reviewed within 125 days.
  • Administrative animal drug applications (administrative NADAs) received during FY 2004 are reviewed within 90 days.

FY 05 Review and Act on 90 percent of:

• • NADAs and reactivations of NADAs received during FY 2005 are reviewed within 270 days.
  • Non-manufacturing supplemental animal drug applications and reactivations of such supplemental applications received during FY 2005 are reviewed within 285 days.
  • Manufacturing supplemental animal drug applications and reactivations of such supplemental applications received during FY 2005 are reviewed within 190 days.
  • Investigational animal drug study submissions received during FY 2005 are reviewed within 285 days.
  • Investigational animal submissions consisting of protocols, that the Agency and the sponsor consider to be an essential part of the basis for making the decision to approve or not approve an animal drug applications or supplemental animal drug application, without substantial data submissions received during FY 2005 are reviewed within 100 days.
  • Administrative NADAs received during FY 2005 are reviewed within 85 days.

FY 06 Review and Act on 90 percent of:

• • NADAs and reactivations of NADAs received during FY 2006 are reviewed within 230 days.
  • Non-manufacturing supplemental animal drug applications and reactivations of such supplemental applications received during FY 2006 are reviewed within 235 days.
  • Manufacturing supplemental animal drug applications and reactivations of such supplemental applications received during 2006 are reviewed within 140 days.
  • Investigational animal drug study submissions received during FY 2006 are reviewed within 235 days.
  • Investigational animal drug submissions consisting of protocols, that the Agency and the sponsor consider to be an essential part of the basis for making the decision to approve or not approve an animal drug application or supplemental animal drug application, without substantial data submissions received during FY 2006 are reviewed within 80 days.
  • Administrative NADAs received during FY 2006 are reviewed within 80 days.

FY 07 Review and Act on 90 percent of:

• • NADAs and reactivations of NADAs received during FY 2007 are reviewed within 200 days.
  • Non-manufacturing supplemental animal drug applications and reactivations of such supplemental applications received during FY 2007 are reviewed within 200 days.
  • Manufacturing supplemental animal drug applications and reactivations of such supplemental applications received during FY 2007 are reviewed within 120 days.
  • Investigational animal drug study submissions received during FY 2007 are reviewed within 200 days.
  • Investigational animal drug submissions consisting of protocols, that the Agency and the sponsor consider to be an essential part of the basis for making the decision to approve or not approve an animal drug application or supplemental animal drug application, without substantial data submissions received during FY 2007 are reviewed within 60 days.
  • Administrative NADAs received during FY 2007 are reviewed within 70 days.

FY 08 Review and Act on 90 percent of:

• • NADAs and reactivations of NADAs received during FY 2008 are reviewed within 180 days.
  • Non-manufacturing supplemental animal drug applications and reactivations of such supplemental applications received during FY 2008 are reviewed within 180 days.
  • Manufacturing supplemental animal drug applications and reactivations of such supplemental applications received during FY 2008 are reviewed within 120 days.
  • Investigational animal drug study submissions received during FY 2008 are reviewed within 180 days.
  • Investigational animal drug submissions consisting of protocols, that the Agency and the sponsor consider to be an essential part of the basis for making the decision to approve or not approve an animal drug application or supplemental animal drug application, without substantial data submissions received during FY 2008 are reviewed within 50 days.
  • Administrative NADAs received during FY 2008 are reviewed within 60 days.

Appendix B: Summary of the ADUFA Performance Goals