[Congressional Record (Bound Edition), Volume 154 (2008), Part 13]
[Senate]
[Pages 18105-18108]
[From the U.S. Government Publishing Office, www.gpo.gov]


                        ANIMAL DRUG USER FEE ACT

  Mr. ENZI. Mr. President, on August 1, 2008, the Senate passed H.R. 
6432, the Animal Drug User Fee Amendments of 2008. Title I of this bill 
includes the reauthorization of the FDA's animal drug user fee program, 
while title II of this bill establishes the FDA's generic animal drug 
user fee program.
  Performance goals, existing outside of the statute, accompany the 
authorization of animal drug user fees and animal generic drug user 
fees. These goals represent realistic projections of what the Food and 
Drug Administration's Center for Veterinary Medicine can accomplish 
with industry cooperation. The Secretary of Health and Human Services 
forwarded these goals to the chairmen of the Committee on Energy and 
Commerce of the House of Representatives and the Committee on Health, 
Education, Labor and Pensions of the Senate, in documents entitled 
``Animal Drug User Fee Act Performance Goals and Procedures'' and 
``Animal Generic Drug User Fee Act Performance Goals and Procedures.''
  According to section 101(b) of H.R. 6432, ``the fees authorized by 
the amendments made in this Act will be dedicated toward expediting the 
animal drug development process and the review of new and supplemental 
animal drug applications and investigational animal drug submissions as 
set forth in the goals identified, for purposes of part 4 of subchapter 
C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the 
letters from the Secretary of Health and Human Services to the Chairman 
of the Committee on Energy and Commerce of the House of Representatives 
and the Chairman of the Committee on Health, Education, Labor, and 
Pensions of the Senate as set forth in the Congressional Record.''
  According to section 201(b) of H.R. 6432, ``the fees authorized by 
this title will be dedicated toward expediting the generic new animal 
drug development process and the review of abbreviated applications for 
generic new animal drugs, supplemental abbreviated applications for 
generic new animal drugs, and investigational submissions for generic 
new animal drugs as set forth in the goals identified in the letters 
from the Secretary of Health and Human Services to the Chairman of the 
Committee on Energy and Commerce of the House of Representatives and 
the Chairman of the Committee on Health, Education, Labor, and Pensions 
of the Senate as set forth in the Congressional Record.''
  Today I am submitting for the Record these documents, on behalf of 
Senator Kennedy, who could not be here today, which were forwarded to 
the Committee on Health, Education, Labor and Pensions on July 30, 
2008, as well as the letter from Secretary Leavitt that accompanied the 
transmittal of this document.
  I ask unanimous consent to have material printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                                  The Secretary of


                                    Health and Human Services,

                                    Washington, DC, July 30, 2008.
     Hon. Edward M. Kennedy,
     Chairman, Committee on Health, Education, Labor and Pensions, 
         U.S. Senate, Washington, DC.
       Dear Mr. Chairman: I am writing to formally transmit the 
     Agreements on the Goals and Procedures for the 
     reauthorization of the Animal Drug User Fee Act and new 
     authorization for Animal Generic Drug User Fees. These 
     documents incorporate the agreement made between the animal 
     drug industry and FDA and contain the goals for the review of 
     animal drug applications over the FY 2009 through FY 2013 
     period. These Goals and Procedures are a companion to the 
     authorizing legislation reauthorizing the animal drug user 
     fees and enacting new animal generic drug fees and they 
     represent the commitment of the Administration to apply the 
     user fees authorized by Congress towards the outlined goals 
     and procedures.
       We appreciate your leadership and considerable efforts of 
     your Committee to make it possible to reauthorize the 
     important animal drug user fee program and enact a 
     corresponding user fee program for generic animal drugs.
           Sincerely,
                                               Michael O. Leavitt.
       Attachments.
                                  ____


       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 2008'' are summarized as follows:
       1. Application/Submission Goals 
       a. 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.
       b. 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.
       c. 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.
       d. The term ``submission date'' is understood to mean the 
     date CVM's Document Control Unit receives an application or 
     submission.
       2. Non-administrative Animal Drug Applications 
       a. The Agency will review and act on 90 percent of non-
     administrative animal drug applications and reactivations of 
     such applications within
       i. 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
       ii. 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
       iii. 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.
       b. 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.
       3. Administration Animal Drug Applications
       a. Review and act on 90 percent of administrative animal 
     drug applications (NADAs submitted after all scientific 
     decisions have

[[Page 18106]]

     been made in the investigational animal drug process, i.e., 
     prior to the submission of the NADA) within 60 days after the 
     submission date.
       4. Non-manufacturing Supplemental Animal Drug Applications
       a. 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 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
       ii. 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
       iii. 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.
       b. 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.
       5. Manufacturing Supplemental Animal Drug Applications
       a. 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.
       6. Investigational Animal Drug Study Submissions
       a. The Agency will review and act on 90 percent of 
     investigational animal drug study submissions within
       i. 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
       ii. 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
       iii. 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.
       b. 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.
       7. Investigational Animal Drug Protocol without Data 
     Submissions
       a. 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
       i. 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
       ii. 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
       iii. 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.
       b. 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.
       c. 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.
       d. 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.
       8. Electronic Review of Applications/Submissions
       a. 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.
       9. Pre-Approval Foreign Inspections
       a. 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.
       b. 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 PAIs is understood to mean the time from the 
     date of scheduling the inspection through notification to the 
     Center of inspectional findings.
       10. Public Workshops
       a. The Agency and regulated industry agree to participate 
     in 10 public workshops by the end of FY 2013 on mutually 
     agreed upon topics.
       11. Additional Efforts Related to Performance Goals
       a. 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.
       b. 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.
       c. 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.

[[Page 18107]]

       d. 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.
       e. 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.
       12. 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:
       a. 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.
       b. 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.
       c. 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.
       d. 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.
       e. The percent of change in the total number of submitted 
     investigational animal drug protocol submissions (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 protocol submissions over the most recent five-
     year period.
                                  ____


   Animal Generic Drug User Fee Act Performance Goals and Procedures

       The goals and procedures of the Food and Drug 
     Administration (FDA or the Agency) as agreed to under the 
     ``Animal Generic Drug User Fee Act of 2008'' are summarized 
     as follows:
       Five-Year Goals (to be implemented by September 30, 2013)
       1. Review and act on 90 percent of non-administrative 
     original abbreviated new animal drug applications (ANADAs) 
     and reactivations of such applications within 270 days after 
     the submission date.
       2. Review and act on 90 percent of manufacturing 
     supplemental ANADAs and reactivations of such supplemental 
     applications within 270 days after the submission date.
       3. Review and act on 90 percent of generic investigational 
     new animal drug (JINAD) study submissions within 270 days 
     after submission date.
       4. Review and act on 90 percent of JINAD 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 ANADA or supplemental ANADA, within 100 days after the 
     submission date.
       5. Review and act on 90 percent of administrative ANADAs 
     (ANADAs submitted after all scientific decisions have been 
     made in the JINAD process, i.e., prior to the submission of 
     the ANADA) within 100 days after the submission date.
       For the application/submission goals above, the term 
     ``review and act on'' is understood to mean the issuance of a 
     complete action letter after the complete review of an 
     original ANADA, supplemental ANADA, or JINAD submission which 
     either (1) approves an original or supplemental ANADA or 
     notifies a sponsor that a JINAD submission is complete or (2) 
     sets forth in detail the specific deficiencies in such 
     original or supplemental ANADA or JINAD submission and, where 
     appropriate, the actions necessary to place such an original 
     or supplemental ANADA or JINAD submission in condition for 
     approval (``incomplete letter''). Within 30 days of 
     submission, FDA shall refuse to file an original or 
     supplemental ANADA, 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 a JINAD 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 original or 
     supplemental ANADAs and JINAD 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 JINAD 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 consider to be an 
     essential part of the basis for making the decision to 
     approve or not approve an original or supplemental ANADA, 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. 
     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 new 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 issues a written order 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.
       The Agency and the regulated industry agree that the use of 
     both formal meetings (e.g., presubmission conferences) and 
     informal communication by both parties is critical to ensure 
     high submission quality such that performance goals can be 
     achieved.
       The term ``submission date'' is understood to mean the date 
     the FDA Center for Veterinary Medicine (CVM) Document Control 
     Unit (DCU) receives an application or submission. DCU date 
     stamps an application or submission on the day of receipt.
       Work Queue Review Procedures
       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 below) will be 
     reviewed with the highest possible priority among those 
     pending.
       Interim Goals
       Interim Application/Submission Goals
       FY09 90 percent of:
       Non-administrative original ANADAs and reactivations of 
     such applications received during FY 2009 are reviewed within 
     700 days after the submission date.

[[Page 18108]]

       Manufacturing supplemental ANADAs and reactivations of such 
     supplemental applications received during FY 2009 are 
     reviewed within 600 days after the submission date.
       JINAD study submissions received during FY 2009 are 
     reviewed within 700 days after the submission date.
       JINAD submissions consisting of protocols without 
     substantial data received during FY 2009 are reviewed within 
     400 days after the submission date.
       Administrative ANADAs received during FY 2009 are reviewed 
     within 120 days after the submission date.
       FY10 90 percent of:
       Non-administrative original ANADAs and reactivations of 
     such applications received during FY 2010 are reviewed within 
     680 days after the submission date.
       Manufacturing supplemental ANADAs and reactivations of such 
     supplemental applications received during FY 2010 are 
     reviewed within 570 days after the submission date.
       JINAD study submissions received during FY 2010 are 
     reviewed within 680 days after the submission date.
       JINAD submissions consisting of protocols without 
     substantial data received during FY 2010 are reviewed within 
     390 days after the submission date.
       Administrative ANADAs received during FY 2010 are reviewed 
     within 115 days after the submission date.
       FY11 90 percent of:
       Non-administrative original ANADAs and reactivations of 
     such applications received during FY 2011 are reviewed within 
     500 days after the submission date.
       Manufacturing supplemental ANADAs and reactivations of such 
     supplemental applications received during FY 2011 are 
     reviewed within 420 days after the submission date.
       JINAD study submissions received during FY 2011 are 
     reviewed within 500 days after the submission date. JINAD 
     submissions consisting of protocols without substantial data 
     received during FY 2011 are reviewed within 290 days after 
     the submission date.
       Administrative ANADAs received during FY 2011 are reviewed 
     within 110 days after the submission date.
       FY12 90 percent of:
       Non-administrative original ANADAs and reactivations of 
     such applications received during FY 2012 are reviewed within 
     380 days after the submission date.
       Manufacturing supplemental ANADAs and reactivations of such 
     supplemental applications received during FY 2012 are 
     reviewed within 340 days after the submission date.
       JINAD study submissions received during FY 2012 are 
     reviewed within 380 days after the submission date.
       JINAD submissions consisting of protocols without 
     substantial data received during FY 2012 are reviewed within 
     190 days after the submission date.
       Administrative ANADAs received during FY 2012 are reviewed 
     within 105 days after the submission date.
       FY13 90 percent of:
       Non-administrative original ANADAs and reactivations of 
     such applications received during FY 2013 are reviewed within 
     270 days after the submission date.
       Manufacturing supplemental ANADAs and reactivations of such 
     supplemental applications received during FY 2013 are 
     reviewed within 270 days after the submission date.
       JINAD study submissions received during FY 2013 are 
     reviewed within 270 days after the submission date.
       JINAD submissions consisting of protocols without 
     substantial data received during FY 2013 are reviewed within 
     100 days after the submission date.
       Administrative ANADAs received during FY 2013 are reviewed 
     within 100 days after the submission date.
       Amending Similar Applications and Submissions
       The Agency and regulated industry agree that applications 
     and submissions to the Agency will be complete and of 
     sufficient quality to allow the Agency's complete and timely 
     review. The Agency will refuse to file poor quality and 
     incomplete applications and submissions rather than allowing 
     them to serve as ``placeholders'' in the review queue that 
     are subsequently amended to add the missing or inadequate 
     portions.
       The Agency recognizes that there are circumstances in which 
     a controlled amendment process can make the review of 
     similar, pending submissions more efficient, without 
     compromising the sponsor's responsibility for high quality 
     submissions. Thus, starting no later than FY 2012, if the 
     Agency requests an amendment to a non-administrative original 
     ANADA, manufacturing supplemental ANADA, JINAD study 
     submission, or a JINAD protocol submission (a ``CVM-initiated 
     amendment''), or issues an incomplete letter for such an 
     application or submission, a sponsor may request to amend 
     other, similar applications or submissions it has pending 
     with the Agency (``sponsor-initiated amendment(s)'') in 
     accordance with the following criteria:
       1. The amended information for these similar applications 
     or submissions must be the same as in the CVM-requested 
     amendment or incomplete letter; and
       2. The amended information must not significantly change 
     the pending application or submission; and
       3. The amended information for these similar applications 
     or submissions must be submitted no later than:
       a. 120 days after the submission date for a pending non-
     administrative original ANADA, manufacturing supplemental 
     ANADA, or JINAD study submission; or
       b. 50 days after the submission date for a pending JINAD 
     protocol.
       If the Agency determines that the above criteria have been 
     met, it will not change the user fee goal for a pending 
     application or submission that has been amended by a sponsor-
     initiated amendment If the above criteria have not been met, 
     the Agency may consider the application or submission 
     resubmitted on the date of the sponsor-initiated amendment, 
     thereby resetting the clock to the date FDA received the 
     amendment.

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