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  5. ADUFA Reauthorization Performance Goals and Procedures of 2008
  1. Animal Drug User Fee Act (ADUFA)

ADUFA Reauthorization Performance Goals and Procedures of 2008

The goals and procedures of the FDA Center for Veterinary Medicine (CVM) as agreed to under the "Animal Drug User Fee Amendments of 2008" are summarized as follows:

Application/Submission Goals

  1. For the application/submission goals below, 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 investigational 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.
  2. FDA may request minor amendments to animal drug applications, supplemental animal drug applications, and investigational animal drug submissions during its review of the application or submission. 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 same policy applies for investigational animal drug submissions.
  3. The term “end-review amendment” is understood to mean an amendment to an animal drug application, supplemental animal drug application, or investigational animal drug submission that is requested by the Agency after it has completed its review of the submitted information and determines that the submission of additional non-substantial data or information would likely complete the application or submission. This term does not include minor amendments requested by the Agency during review of applications or submissions that do not impact upon the user fee goals, as described in paragraph 1.b.
  4. The term “submission date” is understood to mean the date CVM’s Document Control Unit receives an application or submission.

Non-administrative Animal Drug Applications

  1. The Agency will review and act on 90 percent of non-administrative animal drug applications and reactivations of such applications within
    1. 180 days after the submission date (Day 180) if the Agency determines that the application is complete or incomplete. An application is incomplete if it would require substantial data or information to enable the Agency to complete a comprehensive review of the application and reach a decision on the approvability of the application; or
    2. 220 days after the submission date if the Agency determines that the submission of additional non-substantial data or information would likely complete the application and electronically requests an end-review amendment to the application on or before Day 180, but the sponsor fails to file such amendment on or before Day 210. If a sponsor files an amendment after Day 210, then the amendment is ineligible for consideration as an end-review amendment, the extended performance goal (345 days) will not apply, and a complete action letter will be issued by Day 220 for the original application; or
    3. 345 days after the submission date if the Agency electronically requests an end-review amendment to the application on or before Day 180 and the sponsor files an end-review amendment on or before Day 210.
  2. The end-review amendment procedure is not intended to prevent the use of minor amendments during Agency review of an animal drug application as described in paragraph 1.b. above.

Administrative Animal Drug Applications

  1. 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.

Non-manufacturing Supplemental Animal Drug Applications

  1. The Agency will 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
    1. 180 days after the submission date (Day 180) if the Agency determines that the application is complete or incomplete. An application is incomplete if it would require substantial data or information to enable the Agency to complete a comprehensive review of the application and reach a decision on the approvability of the application; or
    2. 220 days after the submission date if the Agency determines that the submission of additional non-substantial data or information would likely complete the application and electronically requests an end-review amendment to the application on or before Day 180, but the sponsor fails to file such amendment on or before Day 210. If a sponsor files an amendment after Day 210, then the amendment is ineligible for consideration as an end-review amendment, the extended performance goal (345 days) will not apply, and a complete action letter will be issued by Day 220 for the original application; or
    3. 345 days after the submission date if the Agency electronically requests an end-review amendment to the application on or before Day 180 and the sponsor files an end-review amendment on or before Day 210.
  2. The end-review amendment procedure is not intended to prevent the use of minor amendments during Agency review of a supplemental new animal drug application as described in paragraph 1.b. above.

Manufacturing Supplemental Animal Drug Applications

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

Investigational Animal Drug Study Submissions

  1. The Agency will review and act on 90 percent of investigational animal drug study submissions within
    1. 180 days after the submission date (Day 180) if the Agency determines that the submission is complete or incomplete. A submission is incomplete if it would require substantial data or information to enable the Agency to complete a comprehensive review of the study submission and reach a decision on the issue(s) presented in the submission; or
    2. 220 days after the submission date if the Agency determines that the submission of additional non-substantial data or information would likely complete the submission and electronically requests an end-review amendment to the submission on or before Day 180, but the sponsor fails to submit such amendment on or before Day 210. If a sponsor submits an amendment after Day 210, then the amendment is ineligible for consideration as an end-review amendment, the extended performance goal (270 days) will not apply, and a complete action letter will be issued by Day 220 for the original submission; or
    3. 270 days after the submission date if the Agency electronically requests an end-review amendment to the submission on or before Day 180 and the sponsor submits an end-review amendment on or before Day 210.
  2. The end-review amendment procedure is not intended to prevent the use of minor amendments during Agency review of a study submission as described in paragraph 1.b. above.

Investigational Animal Drug Protocol without Data Submissions

  1. Review and act on 90 percent of investigational animal drug submissions consisting of protocols without substantial data, 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, within
    1. 60 days after the submission date (Day 60) if the Agency does not request an end-review amendment to the protocol.

      (1) If the Agency determines that the protocol is acceptable, the Agency will notify the sponsor of this decision electronically on or before Day 50, followed by a complete action letter; or

      (2) If the Agency determines that a protocol is not acceptable, the Agency will notify the sponsor of this decision electronically, providing preliminary broad areas of protocol deficiency, on or before Day 50, with the subsequently issued complete action letter providing the detailed protocol assessment. The sponsor may contact the Agency for a brief clarification of these areas of deficiency prior to the issuance of the complete action letter; or

    2. 75 days after the submission date if the Agency electronically requests an end-review amendment to the protocol on or before Day 50, but the sponsor fails to submit such amendment within 10 days of the amendment request date. If a sponsor files an amendment more than 10 days after the amendment request date, then the amendment is ineligible for consideration as an end-review amendment, the extended performance goal (refer to 7.a.iii below) will not apply, and a complete action letter will be issued by Day 75 for the original submission; or
    3. the greater of 60 days after the original protocol is received by the Agency or 20 days after the amended protocol is received by the Agency if the Agency electronically requests an end-review amendment on or before Day 50 and the sponsor submits such amendment within 10 days of the date the amendment is requested.
  2. 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 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, the Agency will issue a complete action letter providing comments resulting from a complete review of the protocol. The complete action 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.
  3. 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 the Agency by written order determines that a substantiated scientific requirement essential to the assessment of the study appeared after the Agency’s protocol assessment, or public or animal health concerns unrecognized at the time of protocol assessment under this process are evident.
  4. The end-review amendment procedure is not intended to prevent the use of minor amendments during Agency review of a protocol without data submission as described in paragraph 1.b. above.

Electronic Review of Applications/Submissions

  1. The Agency will develop an electronic submission tool for industry submissions and online review capability within 24 months of appropriated ADUFA funds for FY 2009. The Agency will consult with the sponsors in the development of this tool.

Pre-Approval Foreign Inspections

  1. The Agency and regulated industry are committed to improving the review and business processes that will facilitate the timely scheduling and conducting of pre-approval inspections (PAIs). To improve the timeliness and predictability of foreign PAIs, sponsors may voluntarily submit 1) at the beginning of the calendar year, a list of foreign manufacturing facilities that are subjects of animal drug applications, supplemental animal drug applications, or investigational animal drug submissions and may be subject to foreign PAIs for the following fiscal year; and 2) a notification 30 days prior to submitting an animal drug application, a supplemental animal drug application, or investigational animal drug submission that informs the Agency that the application includes a foreign manufacturing facility. Should any changes to the annual list occur after its submission to the Agency, the sponsor may provide the updated information to the Agency.
  2. The Agency will keep a record of the number of foreign PAIs conducted for new animal drug applications, along with the average time for completing the PAIs, and include this information in its annual performance report. The time for completing the PAI is understood to mean the time from the inspection scheduling request through notification to the Center of inspectional findings.

Public Workshops

  1. The Agency and regulated industry agree to participate in 10 public workshops by the end of FY 2013 on mutually agreed-upon topics.

Additional Efforts Related to Performance Goals

  1. The Agency will review all submissions in accordance with procedures for working within a queue. An application/submission that is not reviewed within the applicable Application/Submission Goal time frame (noted above) will be reviewed with the highest possible priority among those pending.
  2. The Agency and the regulated industry agree that the use of both formal meetings (e.g., presubmission conferences, workshops, etc.) and informal communication by both parties is critical to ensure high submission quality such that the above performance goals can be achieved.
  3. The Agency and the regulated industry agree to explore and discuss the applicable use of pharmacokinetic/pharmacodynamic data in the development and evaluation of new animal drugs submitted for approval.
  4. The Agency and the regulated industry agree to explore opportunities for exchange of information regarding the characteristics of a new animal drug, and to identify safety and effectiveness issues as early as possible in the drug development process.
  5. The Agency and regulated industry commit to work together to explore shorter timeframes commensurate with the magnitude of the submitted data/information referenced under 11.c and 11.d.

Workload Adjustment

The Animal Drug User Fee Act requires FDA to annually adjust fee revenues after FY 2008 to reflect changes in review workload utilizing a weighted average of animal drug applications, supplemental animal drug applications for which data with respect to safety or effectiveness are required, manufacturing supplemental animal drug applications, investigational animal drug study submissions, and investigational animal drug protocol submissions. The Agency will use the method detailed below to calculate the workload adjustment, and the percent increase in fees will be the amount of the workload adjuster that is greater than one (1.0).

The term “workload adjuster” applicable to a fiscal year consists of the sum of the following 5 components:

  1. The percent of change in the total number of original and reactivated animal drug applications submitted (comparing the five-year average number of such submissions for fiscal years 1998-2002 to the five-year average for the most recent five-year period ending June 30 before the start of the next fiscal year) times a weighting factor that is the percent of direct review time spent on the review of original and reactivated new animal drug applications over the most recent five-year period.
  2. The percent of change in the total number of original and reactivated supplemental animal drug applications submitted for which data with respect to safety or effectiveness are required (comparing the five-year average number of such submissions for fiscal years 1998 - 2002 to the five-year average for the most recent five-year period ending June 30 before the start of the next fiscal year) times a weighting factor that is the percent of direct review time spent on the review of original and reactivated supplemental animal drug applications for which data with respect to safety and effectiveness are required over the most recent five-year period.
  3. The percent of change in the total number of original and reactivated manufacturing supplemental animal drug applications submitted (comparing the five-year average number of such submissions for fiscal years 1998 - 2002 to the five-year average for the most recent five-year period ending June 30 before the start of the next fiscal year) times a weighting factor that is the percent of direct review time spent on the review of original and reactivated manufacturing supplemental animal drug applications over the most recent five-year period.
  4. The percent of change in the total number of investigational animal drug study submissions submitted (comparing the five-year average number of such submissions for fiscal years 1998 – 2002 to the five-year average for the most recent five-year period ending June 30 before the start of the next fiscal year) times a weighting factor that is the percent of direct review time spent on the review of investigational animal drug study submissions over the most recent five-year period.
  5. The percent of change in the total number of submitted investigational animal drug protocol submissions (comparing the five-year average number ofsuch submissions for fiscal years 1998 - 2002 to the five-year average for the most recent five-year period ending June 30 before the start of the next fiscal year) times a weighting factor that is the percent of direct review time spent on the review of investigational animal drug protocol submissions over the most recent five-year period.

Additional Information

 
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