[Congressional Record (Bound Edition), Volume 149 (2003), Part 21]
[Senate]
[Pages 28872-28874]
[From the U.S. Government Publishing Office, www.gpo.gov]




                    ANIMAL DRUG USER FEE ACT OF 2003

  Mr. GREGG. Mr. President, on November 7, 2003, the Senate passed the 
Animal Drug User Fee Act of 2003 which authorizes animal drug user 
fees.
  Performance goals, existing outside of the statute, accompany the 
authorization of animal drug user fees. These goals represent a 
realistic projection 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 Senate Committee on Health, Education, Labor, and 
Pensions, and the House Committee on Energy and Commerce, in a document 
entitled ``Animal Drug User Fee Act Performance Goals and Procedures.'' 
According to Section 2 of ADUFA, ``The fees authorized by 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 
Congressional Record.''
  Today, I am submitting for the Record this document, which was 
forwarded to the Committee on Health, Education, Labor, and Pensions on 
November 13, 2003, as well as the letter from Secretary Thompson that 
accompanied the transmittal of this document.
  I ask unanimous consent they be 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, November 13, 2003.
     Hon. Judd Gregg,
     Chairman, Committee on Health, Education, Labor and Pension,
     U.S. Senate, Washington, DC.
       Dear Mr. Chairman: As you are aware, the Food and Drug 
     Administration has been working with representatives of the 
     veterinary pharmaceutical industry and staff of your 
     Committee to design a new animal drug ``user fee'' proposal. 
     Under this proposal, the additional revenues generated from 
     fees paid by this industry would be dedicated for use in 
     expediting the process for the review of animal drug 
     applications, in accordance with performance goals that have 
     been developed by FDA in consultation with the industry. S. 
     313, the ``Animal Drug User Fee Act of 2003'' reflects the 
     fee mechanisms developed in these discussions. The 
     performance goals are specific in the enclosure to this 
     letter entitled, ``Animal Drug Under Fee Act Performance 
     Goals and Procedures.'' I believe they represent a realistic 
     projection of what FDA can accomplish with industry 
     cooperation and the additional resources that would be 
     provided by the bill and annual FDA appropriations that fully 
     cover the costs of pay and inflation increases for the animal 
     drug review process each year.
       I appreciate the support of you and your staffs, and the 
     assistance of other Members of the Committee.
           Sincerely,
     Tommy G. Thompson.
                                  ____


       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 
     submission 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 application, 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 submission of the NADA) within 60 
     days after 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 animal drug submission 
     which either (1) approves an animal drug application or 
     supplemental animal drug 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.

[[Page 28873]]

     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 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 
     an acknowledgement letter providing comments resulting from a 
     complete review of the protocol. The acknowledgment 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--90 percent of:
       Animal drug applications (NADAs) and reactivations of such 
     applications received during FY 2003 are reviewed within 259 
     days.
       Non-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 
     during FY 2004 are reviewed within 225 days.
       Investigational animal study submissions received during FY 
     2004 are reviewed within 320 days.
       Investigational animal drug submissions 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--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 application 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 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 2005 are reviewed within 
     100 days.
       Administrative NADAs received during FY 2005 are reviewed 
     within 85 days.
     FY 06--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 FY 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.
       Adminstrative NADAs received during FY 2006 are reviewed 
     within 80 days.
     FY 07--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 application 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--90 percent of:
       NADAs and reactivations of NADAs received during FY 2008 
     are reviewed within 120 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.


                          workload adjustment

       The Animal Drug User Fee Act of 2003, requires FDA to 
     annually adjust fee revenues after FY 2004 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 currently intends to utilize the method detailed below 
     to calculate the workload adjustment, and the percent 
     increase in fees will be the amount of the sum of the output 
     from the workload adjuster that is greater than one (1.0). 
     However, the weighting of the specific factors may change in 
     light of discussions with the animal drug industry and the 
     results of ongoing activity based costing analyses within the 
     Center for Veterinary Medicine.
       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 three-year average number of such submissions for fiscal 
     year 2001-2003 to the three-year average for the most recent 
     three year period ending June 30 before the start of the 
     fiscal year) times 3 percent.
       (B) The percent of change in the total number of original 
     and reactivated supplemental animal drug applications for 
     which

[[Page 28874]]

     data with respect to safety or effectiveness are required 
     (comparing the three-year average number of such submissions 
     for fiscal year 2001-2003 to the three-year average for the 
     most recent three year period ending June 30 before the start 
     of the fiscal year) times 12 percent.
       (C) The percent of change in the total number of original 
     and reactivated manufacturing supplemental animal drug 
     applications (comparing the three-year average number of such 
     submissions for fiscal year 2001-2003 to the three-year 
     average for the most recent three year period ending June 30 
     before the start of the fiscal year) times 25 percent.
       (D) The percent of change in the total number of 
     investigational animal drug study submissions (comparing the 
     three-year average number of such submissions for fiscal year 
     2001-2003 to the three-year average for the most recent three 
     year period ending June 30 before the start of the fiscal 
     year) times 46 percent.
       (E) The percent of change in the total number of reviewed 
     investigational animal drug protocol submissions (comparing 
     the three-year average number of such submissions for fiscal 
     year 2001-2003 to the three-year average for the most recent 
     three year period ending June 30 before the start of the 
     fiscal year) times 14 percent.

                          ____________________