[Congressional Record Volume 169, Number 170 (Tuesday, October 17, 2023)]
[Senate]
[Pages S5038-S5044]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




        ANIMAL DRUG AND GENERIC DRUG USER FEE AMENDMENTS OF 2023

  Mr. SANDERS. Mr. President, I ask unanimous consent to have printed 
in the Record at the appropriate place the commitment letters for the 
Animal Drug User Fee Amendments of 2023 and the Animal Generic Drug 
User Fee Amendments of 2023.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

    Animal Drug User Fee Act Reauthorization Performance Goals and 
               Procedures Fiscal Years 2024 Through 2028

       The goals and procedures of the Food and Drug 
     Administration (FDA or the Agency) as agreed to under the 
     ``Animal Drug User Fee Amendments of 2023'' are summarized as 
     follows:


                             I. Definitions

       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 new animal drug (INAD) submission which 
     either (1) approves or conditionally approves an animal drug 
     application or approves a 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 
     INAD submission and, where appropriate, the actions necessary 
     to place such an application, supplemental application, or 
     submission in condition for approval.
       Within 30 days of receipt, FDA shall refuse to file an 
     animal drug application, supplemental new 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 receipt, 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 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. A minor amendment is understood to mean information 
     requested by FDA during the review of the application or 
     investigational submission. FDA may request minor amendments 
     to animal drug applications, supplemental new animal drug 
     applications, and INAD 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 INAD submissions.
       3. The term ``submission date'' or the date of receipt 
     means the date the FDA Center for Veterinary Medicine (CVM) 
     Electronic Submission System (ESS) receives an application or 
     submission. Upon receipt of an application or submission, the 
     CVM ESS creates an electronic receipt that contains the date 
     of receipt and is sent to the submitter.
       4. The term ``labeling supplement'' is understood to mean 
     certain applications as described in 21 CFR 514.8(c)(2)(i)(A) 
     and (D) that require approval of a supplemental application 
     prior to distribution of the drug made using the change.
       5. The term ``presubmission conference'' is understood to 
     mean one or more conferences between a potential applicant 
     and FDA as described in 21 CFR 514.5 to reach a binding 
     agreement establishing a submission or investigational 
     requirement.
       6. The term ``dosage characterization'' is understood to 
     mean a justification of the dosage (dose or dose range, 
     dosing frequency, and the dosing duration) and a 
     characterization of the critical aspects of the dose-response 
     relationship related to each intended use and associated 
     conditions of use.


                    II. Application/Submission Goals

       All applications and submissions under the Federal Food, 
     Drug, and Cosmetic Act sections 512(b) and 571 must be 
     created using the CVM eSubmitter tool and submitted to the 
     Agency through CVM's ESS.
       The submissions in this section are sentinel submissions. 
     CVM's performance toward meeting the associated goals will be 
     included in the performance reports required by section 
     740A(a) of the FD&C Act.
       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 timeframe 
     will be reviewed with the highest possible priority among 
     those pending.
     1. Original New Animal Drug Applications (NADAs), 
         Applications for Conditional Approval (CNADAs), and 
         Reactivations
       Review and act on 90 percent of original NADAs and CNADAs 
     within 180 days after the submission date.
       An application is incomplete if it would require additional 
     data or information to enable the Agency to complete a 
     comprehensive review of the application and reach a decision 
     on the issue(s) presented in the application.
       The Agency will review and act on 90 percent of reactivated 
     applications:
       i. Within 180 days after the reactivated application 
     submission date if the Agency determines and notifies the 
     sponsor that the deficiencies are substantial;
       ii. Within 135 days after the reactivated application 
     submission date if the Agency determines and notifies the 
     sponsor that the deficiencies are not substantial; and the 
     application reactivation must be submitted no more than 120 
     days after the Agency's dated incomplete letter to qualify 
     for the shorter review time; and
       iii. Within 180 days after the reactivated application 
     submission date if the reactivation is submitted after 120 
     days of the Agency's dated incomplete letter or new 
     substantial information is provided in the reactivated 
     application.
       The Agency will generally favor using the shorter 
     reactivation timeframe of 135 days, where possible. The 
     Agency will state in the incomplete letter the appropriate 
     timeframe for review of the reactivation. Sponsors wishing to 
     discuss the selected timeframe should contact the Agency 
     prior to reactivation of the application. The shorter review 
     time of 135 days for reactivated applications for which the 
     deficiencies are determined not to be substantial is not 
     intended to prevent the use of minor amendments during Agency 
     review of an application.
     2. Administrative NADAs and CNADAs
       Review and act on 90 percent of administrative NADAs and 
     CNADAs [(C)NADAs filed after all scientific decisions already 
     have been made as part of the investigational new animal drug 
     process] within 60 days after the filing date.
     3. Non-manufacturing Supplemental NADAs
       Review and act on 90 percent of non-manufacturing 
     supplemental NADAs (i.e., supplemental NADAs for which safety 
     or effectiveness data are required) within 180 days after the 
     submission date.
       A supplemental NADA is incomplete if it would require 
     additional data or information to enable the Agency to 
     complete a comprehensive review of the supplement and reach a 
     decision on the issue(s) presented in the supplement.
       The Agency will review and act on 90 percent of reactivated 
     supplements:
       i. Within 180 days after the reactivated supplemental NADA 
     submission date if the Agency determines and notifies the 
     sponsor that the deficiencies are substantial;
       ii. Within 135 days after the reactivated supplemental NADA 
     submission date if the Agency determines and notifies the 
     sponsor that the deficiencies are not substantial; and the 
     reactivation to the supplemental application must be 
     submitted no more than 120 days after the Agency's dated 
     incomplete letter to qualify for the shorter review time; and
       iii. Within 180 days after the reactivated supplemental 
     NADA submission date if the reactivation to the supplemental 
     application is submitted after 120 days of the Agency's dated 
     incomplete letter or new substantial information is provided 
     in the reactivated supplement.
       The Agency will generally favor using the shorter 
     reactivation timeframe of 135 days, where possible. The 
     Agency will state in the incomplete letter the appropriate 
     timeframe for review of the reactivation. Sponsors wishing to 
     discuss the selected timeframe should contact the Agency 
     prior to the reactivation of the supplement. The shorter 
     review time of 135 days for reactivated supplements for which 
     the deficiencies are determined not to be substantial is not 
     intended to prevent the use of minor amendments during Agency 
     review of a supplemental application.
     4. Prior Approval Manufacturing Supplemental Animal Drug 
         Applications and Reactivations
       Review and act on 90 percent of Prior Approval 
     manufacturing supplemental animal drug applications within 
     120 days after the submission date. A Prior Approval 
     manufacturing supplemental application includes: one or more 
     major manufacturing changes as described in 21 CFR 
     514.8(b)(2)(ii) and in accordance with Guidance for Industry 
     83 (Chemistry, Manufacturing, and Controls Changes to an 
     Approved NADA or ANADA); and, changes submitted as 
     ``Supplement-

[[Page S5039]]

     Changes Being Effected in 30 Days'' that require prior 
     approval according to 21 CFR 514.8(b)(3)(v)(A). If a Prior 
     Approval supplement does not clearly identify any major 
     manufacturing changes, the Prior Approval supplement will be 
     designated by the Agency as a ``Supplement-Changes Being 
     Effected'' with a 180 days review goal (see ``Supplement-
     Changes Being Effected Manufacturing Supplemental Animal Drug 
     Applications and Reactivations'' below).
       A submission is incomplete if it requires additional data 
     or information to enable the Agency to complete a 
     comprehensive review of the submission and reach a decision 
     on the issue(s) presented in the submission. If the Agency 
     determines that the deficiencies are not substantial for 
     manufacturing supplements requiring prior approval, the 
     Agency will allow the manufacturing supplements to be 
     resubmitted as ``Supplement-Changes Being Effected in 30 
     Days'' as described in 21 CFR 514.8(b)(3) and the drug made 
     with the change can be distributed 30 days after the 
     resubmission according to 21 CFR 514.8(b)(3)(iv). The Agency 
     will review and act on 90 percent of these reactivated 
     manufacturing supplements within 180 days after the 
     resubmission date of a complete submission. If the Agency 
     determines that the deficiencies remain substantial or new 
     substantial information is provided, prior-approval is 
     required according to 21 CFR 514.8(b)(3)(v)(A). The Agency 
     will review and act on 90 percent of these reactivated 
     manufacturing supplements within 120 days after the 
     resubmission date of a complete submission.
     1. Supplements--Changes Being Effected Manufacturing 
         Supplemental Animal Drug Applications and Reactivations
       Review and act on 90 percent of ``Supplement- Changes Being 
     Effected'' manufacturing supplemental applications and 
     reactivations submitted according to 21 CFR 514.8(b)(3)(vi) 
     and in accordance with Guidance for Industry 83 (Chemistry, 
     Manufacturing, and Controls Changes to an Approved NADA or 
     ANADA), including manufacturing changes not requiring prior 
     approval according to 21 CFR 514.8(b)(3) within 180 days 
     after the submission date.
     2. Investigational New Animal Drug (INAD) Study Submissions
       Review and act on 90 percent of INAD study submissions 
     within 180 days after the submission date.
       An INAD study submission is incomplete if it would require 
     additional data or information to enable the Agency to 
     complete a comprehensive review of the submission and reach a 
     decision on the issue(s) presented in the submission.
       The Agency will review and act on 90 percent of 
     resubmissions:
       i. Within 180 days after the resubmitted INAD study 
     submission date if the Agency determines and notifies the 
     sponsor that the deficiencies are substantial;
       ii. Within 60 days after the resubmitted INAD study 
     submission date if the Agency determines and notifies the 
     sponsor that the deficiencies are not substantial; and the 
     resubmission must be submitted no more than 120 days after 
     the Agency's dated incomplete letter to qualify for the 
     shorter review time; and
       iii. Within 180 days after the resubmitted INAD study 
     submission date if the resubmission is submitted after 120 
     days of the Agency's dated incomplete letter or new 
     substantial information is provided in the resubmission.
       The Agency will generally favor using the shorter 
     resubmission timeframe of 60 days, where possible. The Agency 
     will state in the incomplete letter the appropriate timeframe 
     for review of the resubmission. Sponsors wishing to discuss 
     the selected timeframe should contact the Agency prior to 
     resubmitting the application. The shorter review time of 60 
     days for resubmissions for which the deficiencies are 
     determined not to be substantial is not intended to prevent 
     the use of minor amendments during Agency review of a 
     submission.
       Review and act on 90 percent of microbial food safety 
     hazard characterization submissions within 100 days after the 
     submission date.
     7. INAD Study Protocols without Data Submissions
       Review and act on 90 percent of INAD submissions consisting 
     of protocols without 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, within 50 days after the submission date.
       An INAD protocol without data submission is incomplete if 
     it would require additional information to enable the Agency 
     to complete a comprehensive review of the protocol and reach 
     a decision on the issue(s) presented in the protocol.
       The Agency will review and act on 90 percent of resubmitted 
     INAD protocol without data submissions:
       i. Within 50 days after the resubmission date if the Agency 
     determines and notifies the sponsor that the deficiencies are 
     substantial;
       ii. Within 20 days after the resubmitted INAD protocol 
     without data submission date if the Agency determines and 
     notifies the sponsor that the deficiencies are not 
     substantial; and the resubmission must be submitted no more 
     than 120 days after the Agency's dated non-concurrence letter 
     to qualify for the shorter review time; and
       iii. Within 50 days after the resubmission date if the 
     resubmission is submitted after 120 days of the Agency's 
     dated non-concurrence letter or new substantial information 
     is provided in the resubmission.
       The Agency will generally favor using the shorter 
     resubmission timeframe of 20 days, where possible. The Agency 
     will state in the non-concurrence letter the appropriate 
     timeframe for review of the resubmission. Sponsors wishing to 
     discuss the selected timeframe should contact the Agency 
     prior to resubmission of the protocol without data. The 
     shorter review time of 20 days for resubmitted INAD protocol 
     without data submissions for which the deficiencies are 
     determined not to be substantial is not intended to prevent 
     the use of minor amendments during Agency review of a 
     submission.
       Sponsors are not required to submit study protocols for 
     review. However, for each protocol voluntarily submitted 
     prior to the commencement of the 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.
       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.
       The Agency will permit comparability protocols as described 
     in 21 CFR 514.8(b)(2)(v) to be submitted as protocols without 
     substantial data in an INAD file. The Agency will review and 
     act on 90 percent of INAD submissions consisting of protocols 
     without substantial data within 50 days after the submission 
     date of the protocol. For potentially more complex 
     comparability protocols, for example sterile process 
     validation protocols, the sponsor should discuss and have 
     Agency concurrence regarding the appropriate filing strategy.
     8. Qualifying Labeling Supplements
       Review and act on 90 percent of qualifying labeling 
     supplements as described in 21 CFR 514.8(c)(2)(i)(A) and (D) 
     within 60 days after the submission date. Qualifying labeling 
     supplements are defined as those for which the sponsor 
     provides and certifies a complete list of labeling changes 
     made in the application and that CVM can determine upon 
     initial review do not decrease the safety of drug use.
       The Agency will review and act on 90 percent of non-
     qualifying labeling supplements within 180 days after the 
     submission date.
     9. Presubmission Conferences
       Conduct 90% of qualifying presubmission conferences within 
     a 60-day timeframe, regardless of forum, when all of the 
     following conditions are met:
       i) All background materials, including presentations, have 
     been submitted, and
       ii) A complete agenda has been agreed upon by the Agency 
     and the sponsor.
       If a sponsor requests a date beyond the 60-day timeframe 
     for their scheduling purposes or is unable to meet with the 
     FDA on Agency-available dates within the 60-day timeframe, 
     the submission will be excluded from the presubmission 
     conference cohort.
     10. Categorical Exclusions
       Review and act on 90 percent of resubmissions of a 
     previously completed Environmental Impact technical section 
     within 60 days after the resubmission date where:
       i. A Categorical Exclusion was issued;
       ii. All other technical sections have been submitted; and
       iii. Information contained in the other technical sections 
     reveals a change in the conditions of use of the drug that 
     may affect the previous determination of categorical 
     exclusion.
     11. Tissue Residue Methods
       Commence 90% of tissue residue method demonstrations within 
     120 days of completion of the ``3-hour meeting'' process or 
     equivalent process milestone where there is a single 
     laboratory validation tissue residue method demonstration.
     12. Animal Drug Availability Act (ADAA) Combination Medicated 
         Feeds Applications
       Review and act on 90 percent of qualifying ADAA Combination 
     Medicated Feeds Applications within 60 days after the 
     submission date. An ADAA combination application will qualify 
     for the 60-day review timeframe only if the following 
     criteria are met:
       i. The regulatory requirements for an ADAA combination 
     application have been met as outlined in 21 CFR 
     514.4(c)(2)(ii)

[[Page S5040]]

       ii. The submission meets all of the eligibility criteria 
     found in section II of P&P 1243.5730, ``Review of 60-Day 
     Original Animal Drug Availability Act of 1996 (ADAA) Feed Use 
     Combination New Animal Drug Applications (NADAs).''
       Review and act on 90 percent of ADAA combination 
     applications within 100 days for those applications initially 
     accepted for the 60-day timeframe but subsequently determined 
     to need minor amendments.
       If any of the above conditions cannot be met, the ADAA 
     combination application will be given a 180-day review 
     timeframe and placed in the original NADA application cohort.


                   III. ADDITIONAL PERFORMANCE GOALS

       Submissions in this section are not sentinel submissions 
     unless they appear in section II, above.
     A. Foreign inspections

                  1. 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 specified in an 
     animal drug application, supplemental animal drug 
     application, or investigational animal drug submission 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 
     INAD submission that informs the Agency that the application/
     submission 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 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.

                       2. Foreign GMP Inspections

       The Agency commits to working to implement and maintain the 
     United States and European Union, and the United States and 
     United Kingdom, Good Manufacturing Practice mutual 
     recognition agreements and future mutual recognition 
     agreements with respect to animal drug products subject to 
     review.
       Beginning in fiscal year (FY) 2024, the Agency will report 
     quarterly in FDA-TRACK the percentage of pre-approval 
     inspection risk decisions which relied at least in part on 
     information from inspections recognized under a mutual 
     recognition agreement with a foreign regulatory authority.
     B. Meetings

              1. Presubmission Conferences Held Virtually

       Beginning on October 1, 2023, for qualifying presubmission 
     conferences where the sponsor requests that the conference be 
     held virtually (not in person), the Agency will provide the 
     following:
       At least 6 days prior to the scheduled presubmission 
     conference date, written responses to the questions posed by 
     the sponsor in their meeting request. Responses will be 
     commensurate to the level of information and complexity of 
     questions submitted by the sponsor.
       Permit the sponsor to cancel the scheduled presubmission 
     conference should the Agency's written responses provide all 
     the information they were seeking from the Agency.
       Should the presubmission conference be held, provide a 
     memorandum of conference within 30 days after the 
     presubmission conference date.
       Sponsors may request a virtual presubmission conference and 
     opt out of the process above. The sponsor will identify their 
     decision whether to opt out of the above process within the 
     presubmission conference request. If the sponsor chooses to 
     opt out, the Agency will not issue any written responses 
     before the presubmission conference and will provide a 
     memorandum of conference within 45 days following the 
     presubmission conference date.

                       2. Stakeholder Engagement

       a. The Agency is committed to engaging with all our 
     external stakeholders in substantive ways that work for all 
     parties. Further, the Agency commits to coordinating with AHI 
     to identify the most appropriate forum based on topic, 
     timing, and public health safety precautions with the 
     understanding that it is a priority for AHI to meet in person 
     when possible.
       b. FDA will host triannual meetings (three times a calendar 
     year) with the Animal Health Institute (AHI) members.
       c. During one triannual meeting with AHI per calendar year, 
     the Agency will dedicate up to 8 hours for an education 
     session intended for the animal drug industry. These sessions 
     will be open to the public and hosted in an appropriate 
     forum. The Agency and AHI will build a plan of educational 
     topics for the five years of the ADFUA V program period. 
     Education sessions will be recorded and posted publicly to 
     the Agency's ``For Industry'' website in a new ``Education 
     for Industry'' section.
       d. The Agency will conduct an industry engagement sub-
     meeting during each AHI triannual meeting, that includes CVM 
     leadership and designated AHI attendees and uses a structured 
     agenda to provide updates on metrics and performance related 
     to the ADUFA program and resource utilization (i.e., CVM 
     staffing).
     C. H submissions

   1) Supporting Information for Presubmission Conferences and INAD 
                   Protocols without Data Submissions

       The Agency and the regulated industry agree that data and/
     or information which uniquely describes the general 
     attributes of the new animal drug (e.g., the known 
     characteristics of the drug that can impact safety, 
     effectiveness and/or quality) needs to be submitted early in 
     the new animal drug development process in order to enable 
     the parties to reach agreement at a presubmission conference 
     or to begin review of a protocol. The intent of this 
     provision is to avoid the submission of data or information 
     between the presubmission conference and the submission of a 
     protocol. Eligibility both for short justifications in 
     protocols and for concurrent supporting data and protocol 
     review described below is predicated on the sponsor 
     submitting information early in the new animal drug 
     development process.
       The Agency will allow for the inclusion of these data and/
     or information in presubmission conferences and/or in an H 
     submission prior to the presubmission conference; however, a 
     presubmission conference may be held without such data. By 
     October 1, 2023, the Agency will publish a Program Policy and 
     Procedures Manual Guide (P&P) for CVM reviewers who are 
     advising sponsors on:
       information/data included in H submissions related to 
     presubmission conferences,
       timing of the related meeting request submission, and
       how CVM should schedule meetings, such that they occur on, 
     or in close proximity to, the H submission due date.
       The Agency will allow short justifications within INAD 
     protocols without data submissions that are limited in scope 
     (e.g., no more than ten pages or no more than two (peer-
     reviewed) journal articles).
       The Agency will allow for the concurrent submission of 
     supporting data (INAD H submissions) and protocols (INAD E 
     submissions) provided that the protocol is not submitted 
     until the supporting data has been in the Agency's queue for 
     at least 50 days.
       By October 1, 2023, the Agency will publish a P&P for CVM 
     reviewers who are advising sponsors regarding the appropriate 
     timing of a protocol submission in relation to an H 
     submission containing information to support the protocol. 
     The P&P will address situations where information was 
     submitted early in the new animal drug development process, 
     as described earlier in this section, and situations where 
     this information was not submitted early in the animal drug 
     development process. The P&P will provide information to CVM 
     staff who are advising sponsors about when a protocol may or 
     may not be submitted after the supporting data has been in 
     the Agency's queue for at least 50 days.

                       2. Dosage Characterization

       The Agency and the regulated industry agree that dosage 
     characterization is part of the effectiveness technical 
     section of an investigational new animal drug file. In 
     instances where data and/or information about the dosage are 
     integral to the review of a protocol, the Agency and the 
     regulated industry agree that these data and/or information 
     should be submitted as supporting data (INAD H submission) 
     well in advance of the protocol submission. Such information 
     may be needed to ensure selection of optimal study time 
     points and would be particularly important for novel drugs 
     and drugs with modified-release characteristics.

                  3. Raw Data Submission Expectations

       By October 1, 2024, the Agency will publish a draft 
     Guidance for Industry on raw data submission expectations for 
     non-clinical studies conducted under Good Laboratory Practice 
     requirements and clinical studies conducted under Good 
     Clinical Practice requirements.
       By October 1, 2023, the Agency will publish a P&P for CVM 
     reviewers reviewing H submissions in which the sponsor is 
     seeking agreement on a proposed list of copies of raw data 
     and documents related to their submission of a target animal 
     safety (TAS) protocol without data submission. After 
     publication of the P&P, CVM will permit the submission of H 
     submissions containing a proposed list of copies of raw data 
     and documents supporting a TAS protocol.

              4. eSubmitter and H Submissions for Raw Data

       By October 1, 2023, FDA will launch a new or updated 
     eSubmitter template for TAS protocols, to facilitate 
     efficient review of the H submissions containing proposed raw 
     data to be included in TAS study reports, provided that 
     industry stakeholders that use the eSubmitter tool have 
     provided timely feedback to further the Agency's work. FDA 
     will continue to accept stakeholder feedback on the 
     eSubmitter template for these H submissions during ADUFA V.
       The Agency and industry stakeholders will assess the 
     benefits of the eSubmitter template for H submissions for TAS 
     protocols before the Agency develops a template for H 
     submissions for effectiveness protocols. If the Agency 
     proceeds with the template for H submissions for 
     effectiveness protocols, industry stakeholders that use the 
     eSubmitter

[[Page S5041]]

     tool will be invited to provide timely feedback to advance 
     the Agency's work.
     D. Exploration with Industry

   1. Animal Drug Availability Act (ADAA) Combination Medicated Feeds

       The Agency agrees to explore, in concert with affected 
     parties including the animal health industry, CVM P&P 
     1243.5730, ``Review of 60-day original Animal Drug 
     Availability Act of 1996 (ADAA) feed use combination new 
     animal drug applications (NADAs)'', to determine why the 
     process is not being utilized and to understand how to 
     increase utilization of the process, thereby reducing the 
     review time for eligible ADAA combinations drug applications 
     following the approval of a new Type A medicated article. The 
     exploration phase will be completed by October 1, 2025. The 
     Agency may revise P&P 1243.5730 based on the outcome of the 
     exploration phase.

                        2. Residue Method Trial

       The Agency agrees to explore, in concert with affected 
     parties including the animal health industry, the drug 
     residue analytical method trial process and its requirements 
     as they relate to the approval of new animal drugs intended 
     for food producing animals. If implementation of 
     recommendations is possible, it may include modification of 
     current processes. Implementation also may include 
     procedural, policy, and/or guidance revisions. The 
     exploration phase will be completed by October 1, 2025. 
     Implementation of actionable recommendations will be 
     completed during ADUFA V.

                   3. Sentinel Submission Clock Stop

       Beginning on October 1, 2023, the Agency agrees to explore, 
     in concert with industry, the feasibility of using additional 
     review tools to enhance the efficiency of the animal drug 
     review process, such as implementing a ``clock stop'' during 
     the review of sentinel submissions. A working group will 
     develop a written analysis and recommendations for the tools 
     identified by September 30, 2025.

                4. Feedback on Product Development Plans

       The Agency agrees to explore, in concert with affected 
     parties including the animal health industry, means for the 
     Agency to provide feedback on a sponsor's animal drug 
     development plan more efficiently and effectively for both 
     industry and the Agency. By October 1, 2025, a working group 
     will develop a report outlining suggestions for providing 
     feedback.
     E. Other

               1. Chemistry, Manufacturing, and Controls

       By September 30, 2024, the Agency will publish a P&P for 
     Chemistry, Manufacturing, and Controls (CMC) reviewers to 
     clarify when reviewers should request amendments, use 
     shortened review time, or classify submissions as incomplete. 
     In addition, this P&P will describe what administrative 
     actions are appropriate when GMP status (or pending PAI) is 
     the only comment remaining for a CMC technical section.
       By September 30, 2024, the Agency will revise Guidance for 
     Industry 227 ``Two-Phased Chemistry, Manufacturing, and 
     Controls (CMC) Technical Sections'' to define situations for 
     which parallel submission of phased data submissions would be 
     allowed.


                         IV. REPORTING METRICS

     A. Sentinel Submissions Filed/Submitted at Division Level
       Beginning in FY 2024, as part of the annual ADUFA V 
     performance report, FDA will report the number of certain 
     filed/submitted sentinel submissions by review division. 
     Performance will be reported at the program level. The 
     sentinel submissions are:
       1. Original NADAs, CNADAs and reactivations
       2. Administrative NADAs and CNADAs
       3. Non-manufacturing supplemental NADAs and reactivations
       4. INAD study submissions
       5. INAD study protocols without data submissions
       6. Qualifying labeling supplements
       7. Presubmission conferences
     B. Time in Agency/Time in Industry
       Beginning in FY 2024, in concert with industry, explore 
     potential Agency-reported metrics regarding review time of 
     investigational submissions that lead to approvals by the 
     Agency and response time by industry. The exploration may 
     include discussions on which metrics to report, what 
     processes currently exist to calculate and report these 
     metrics, which systems might need to be developed to 
     facilitate reporting the metrics, what the results of the 
     metrics mean, and how best to report the metrics.
       Following publication of the third-party assessment in 
     2025, industry and the Agency will initiate a follow up 
     effort, which may include a pilot period, to inform how these 
     metrics might be collected and reported.
     C. Favorable Outcomes
       Beginning in the second quarter (Q2) of FY 2024, FDA will 
     report quarterly in FDA-TRACK, for INAD protocols without 
     data and for INAD study submissions, the number of the 
     following outcomes: (1) favorable, (2) non-concurrence/non-
     accepted but shortened review offered, and (3) non-
     concurrence/non-accepted and shortened review not offered.
       FDA and industry will work together to identify a process 
     to annually report the cycle number for all for INAD 
     protocols without data and INAD study submissions with 
     favorable outcomes and whether the favorable outcomes were 
     first, second, or third+ submissions.
       FDA and industry will work together to make sustained, 
     substantial, and incremental improvements in the annual 
     percentage of favorable outcomes for the CMC INAD study 
     submissions and/or to improve utilization of the shortened 
     review process.
     D. INAD H Submissions Submitted at Division Level
       Beginning in Q2 of FY 2024, FDA will report quarterly in 
     FDA-TRACK the number of H submissions submitted to ONADE by 
     division.
     E. Average Review Times in Hours
       Beginning in FY 2024, FDA will report in the ADUFA 
     performance report the average review times, in hours, for 
     protocols without data and INAD study submissions (broken 
     down by technical section) by fiscal year.


             V. ENHANCING MANAGEMENT OF USER FEE RESOURCES

       FDA is committed to enhancing management of ADUFA resources 
     and ensuring ADUFA user fee resources are administered, 
     allocated, and reported in an efficient and transparent 
     manner.
     A. Third-Party Assessment
       The Agency will engage an independent, third-party to 
     conduct a comprehensive assessment of the process for the 
     review of animal drug applications. The assessment will 
     include consultation with both the Agency and industry. The 
     assessment will include first cycle reviews as they pertain 
     to the ADUFA program's objective of expediting the animal 
     drug development process and the review of new and 
     supplemental animal drug applications and investigational 
     animal drug submissions.
       The assessment will examine past and current utilization 
     and effectiveness of the review process, available resources 
     [e.g., full-time equivalents (FTEs)], and tools used by the 
     Agency and industry, as established through previous ADUFA 
     authorizations to foster favorable first cycle review 
     outcomes for sentinel submissions. The scope of this 
     assessment will include the analysis of submissions (starting 
     from the request to establish an INAD file and ending with 
     approval) and include all technical section submissions (both 
     sentinel and non-sentinel) to INAD files, NADAs, and 
     conditional approval application files. It will also evaluate 
     the impact of specific user fee-based enhancements from prior 
     reauthorizations on approved original NADAs and applications 
     for conditional approval.
       The assessment will include evaluation of a random set of 
     applications approved from FY 2009 through FY 2022. The 
     samples will include representation from new chemical 
     entities, multiple animal drug sponsors, all major 
     species, and multiple different dosage form. The 
     evaluation will include the proposal and evaluation of the 
     optimal process to provide data on how resources are 
     utilized (i.e., user fee funds; headcount and process FTEs 
     with ADUFA allowable activities by office and division) 
     and of applicable metrics (e.g., time to approval, divided 
     between time in agency and time with industry, for 
     technical sections to INADs and NADAs; and favorable first 
     cycle outcomes) that evaluate progress towards the ADUFA 
     program's objective mentioned above.
       The Agency will obtain the services of a contractor to 
     complete this assessment. After the final assessment report 
     is accepted by the responsible Agency official, it will be 
     posted on FDA.gov. When publishing the final assessment 
     report on the FDA website, the Agency will comply with 
     requirements to protect confidential commercial information 
     and other information exempt from disclosure.
       FDA will convene a public workshop approximately three 
     months after accepting the final assessment report to present 
     the findings of the independent assessment, including the 
     third-party's report of anonymized, aggregated feedback 
     resulting from its interviews of animal drug sponsors and 
     Agency personnel. The assessment report and the public 
     meeting will be completed by December 31, 2025.
       Following the completion of the assessment and public 
     meeting, the Agency and industry will analyze the 
     recommendations for improvement opportunities identified in 
     the assessment. FDA, with input from stakeholders, will 
     incorporate findings and recommendations, as it determines to 
     be possible and appropriate, into its management of the 
     process for the review of animal drug applications and 
     Industry will incorporate findings and recommendations, as 
     appropriate, into their filing and submission processes.
     B. Financial Transparency
       1. FDA will publish an ADUFA 5-year financial plan no later 
     than the end of the second quarter of FY 2024 that aligns 
     with the plans published for GDUFA II, PDUFA VI and BsUFA II.
       2. FDA will publish updates to the 5-year plan no later 
     than the end of the second quarter of each subsequent fiscal 
     year.


                       VI. Statutory Adjustments

     A. Workload Adjustment
       For the purposes of calculating the workload adjustment, 
     the base years will be a rolling average comprising the five 
     most recently completed fiscal years. For example, beginning 
     October 1, 2024 (FY 2025), the base will comprise FY 2019 
     through FY 2023. At the start of each fiscal year thereafter, 
     the base will be adjusted upward by one year on the upper and 
     lower ends of the range. There will be no workload adjustment 
     for FY 2024.

[[Page S5042]]

     Workload adjustments are one-time adjustments and are 
     calculated annually. The weighting factor is the percent of 
     direct review time spent on each of the five component 
     submission types over the most recent five-year period.
       As stated in the Federal Food, Drug, and Cosmetic (FD&C) 
     Act, the workload adjustment ``shall be made for each fiscal 
     year that the adjustment determined by the Secretary is 
     greater than 3 percent, except for the first fiscal year that 
     the adjustment is greater than 3 percent, except for the 
     first fiscal year that the adjustment is greater than 3 
     percent.'' See section 740(c)(3) of the FD&C Act [21 U.S.C. 
     379j-12(c)(3)] for the full text of the workload adjustment.
     B. Operating Reserve Adjustment
       The operating reserve of carryover user fees for the 
     process for the review of animal drug applications will be 
     used to fund the third-party assessment described in section 
     V.A. and any ADUFA V negotiated, one-time IT enhancements.
       Additionally, as stated in the FD&C Act, fee revenue 
     amounts will be adjusted to provide an operating reserve of 
     carryover user fees for the process of the review of animal 
     drug applications of not less than 12 weeks and not more than 
     16 weeks. The reduction of the operating reserve to the 16-
     week maximum will be phased in over the 5-year lifecycle of 
     ADUFA V. Section 740(c)(4) of the FD&C Act [21 U.S.C. 379j-
     12(c)(4)] contains the text of the operating reserve 
     adjustment, as follows:
       ``(4) OPERATING RESERVE ADJUSTMENT.--
       ``(A) IN GENERAL.--For fiscal year 2025 and each subsequent 
     fiscal year, after the fee revenue amount established under 
     subsection (b) is adjusted in accordance with paragraphs (2) 
     and (3), the Secretary shall--
       (i) increase the fee revenue amount for such fiscal year, 
     if necessary to provide an operating reserve of not less than 
     12 weeks; or
       (ii) if the Secretary has an operating reserve in excess of 
     the number of weeks specified in subparagraph (C) for that 
     fiscal year, the Secretary shall decrease the fee revenue 
     amount to provide not more than the number of weeks specified 
     in subparagraph (C) for that fiscal year.
       (B) CARRYOVER USER FEES.--For purposes of this paragraph, 
     the operating reserve of carryover user fees for the process 
     for the review of animal drug applications does not include 
     carryover user fees that have not been appropriated.
       (C) NUMBER OF WEEKS OF OPERATING RESERVES.--The number of 
     weeks of operating reserves specified in this subparagraph 
     is--
       ``(i) 22 weeks for fiscal year 2025;
       ``(ii) 20 weeks for fiscal year 2026;
       ``(iii) 18 weeks for fiscal year 2027; and
       ``(iv) 16 weeks for fiscal year 2028.

Animal Generic Drug User Fee Act Reauthorization Performance Goals and 
               Procedures--Fiscal Years 2024 Through 2028

       The goals and procedures of the Food and Drug 
     Administration (FDA or the Agency) as agreed to under the 
     Animal Generic Drug User Fee Amendments of 2023 are 
     summarized as follows:

                      Application/Submission Goals

       Beginning October 1, 2023, all applications and submissions 
     under the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
     section 512(b) must be created using the eSubmitter tool and 
     submitted to the Agency through the FDA Center for Veterinary 
     Medicine (CVM) Electronic Submission System (ESS).
       1. Original Abbreviated New Animal Drug Applications 
     (ANADAs) and Reactivations
       Review and act on 90 percent of original ANADAs within 240 
     days after the submission date.
       An application is incomplete if it would require additional 
     data or information to enable the Agency to complete a 
     comprehensive review of the application and reach a decision 
     on the issue(s) presented in the application. If the Agency 
     determines that the deficiencies are not substantial, the 
     Agency will review and act on 90 percent of reactivated 
     applications within 120 days after the reactivated ANADA 
     submission date. This shorter review time for reactivated 
     ANADAs for which the deficiencies are determined not to be 
     substantial is not intended to prevent the use of minor 
     amendments during Agency review of an application. If the 
     Agency determines that the deficiencies are substantial or 
     new substantial information is provided, the Agency will 
     review and act on 90 percent of reactivated applications 
     within 240 days after the reactivated ANADA submission date.
       2. Administrative ANADAs
       Review and act on 90 percent of administrative ANADAs 
     (ANADAs submitted after all scientific decisions have been 
     made in the generic investigational new animal drug (JINAD) 
     process, i.e., prior to the submission of the ANADA) within 
     60 days after the submission date. Paragraph IV certification 
     applications (FD&C Act section 512(n)(1)(H)(iv)) submitted as 
     administrative ANADAs will be excluded from the 
     administrative ANADA cohort.
       3. Prior Approval Manufacturing Supplemental ANADAs and 
     Reactivation
       Review and act on 90 percent of Prior Approval 
     manufacturing supplemental ANADAs within 180 days after the 
     submission date. A Prior Approval manufacturing supplemental 
     ANADA includes: one or more major manufacturing changes 
     according to 21 CFR 514.8(b)(2)(ii) and in accordance with 
     Guidance for Industry 83 (Chemistry, Manufacturing, and 
     Controls Changes to an Approved NADA or ANADA); and, changes 
     submitted as ``Supplement-Changes Being Effected in 30 Days'' 
     that require prior approval according to 21 CFR 
     514.8(b)(3)(v)(A). If a Prior Approval supplement does not 
     clearly identify any major manufacturing changes, the Prior 
     Approval supplement will be designated by the Agency as a 
     ``Supplement-Changes Being Effected'' with a 270 days review 
     goal (see ``Supplement-Changes Being Effected Manufacturing 
     Supplemental ANADAs and Reactivations'' below).
       A submission is incomplete if it requires additional data 
     or information to enable the Agency to complete a 
     comprehensive review of the submission and reach a decision 
     on the issue(s) presented in the submission. If the Agency 
     determines that the deficiencies are not substantial for 
     manufacturing supplements requiring prior approval, the 
     Agency will allow the manufacturing supplements to be 
     resubmitted as ``Supplement-Changes Being Effected in 30 
     Days'' as described in 21 CFR 514.8(b)(3) and the drug made 
     with the change can be distributed 30 days after the 
     resubmission according to 21 CFR 514.8(b)(3)(iv). The Agency 
     will review and act on 90 percent of these reactivated 
     manufacturing supplements within 270 days after the re-
     submission date of a complete submission. If the Agency 
     determines that the deficiencies remain substantial or new 
     substantial information is provided, prior-approval is 
     required according to 21 CFR 514.8(b)(3)(v)(A). The Agency 
     will review and act on 90 percent of these reactivated 
     manufacturing supplements within 180 days after the re-
     submission date of a complete submission.
       4. Supplement--Changes Being Effected Manufacturing 
     Supplemental ANADAs and
       Review and act on 90 percent of ``Supplement-Changes Being 
     Effected'' manufacturing supplemental ANADAs and 
     reactivations submitted according to 21 CFR 514.8(b)(3)(vi) 
     and in accordance with Guidance for Industry 83 (Chemistry, 
     Manufacturing, and Controls Changes to an Approved NADA or 
     ANADA), including manufacturing changes not requiring prior 
     approval according to 21 CFR 514.8(b)(3)(iv), within 270 days 
     after the submission date.
       5. Generic Investigational New Animal Drug (JINAD) Study 
     Submissions
       Review and act on 90 percent of JINAD study submissions 
     within 180 days after the submission date.
       A submission is incomplete if it would require additional 
     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. If the 
     Agency determines that the deficiencies are not substantial, 
     the Agency will review and act on 90 percent of resubmitted 
     JINAD study submissions within 60 days after the receipt date 
     of a complete study submission. This shorter review time for 
     resubmitted JINAD study submissions is not intended to 
     prevent the use of minor amendments during Agency review of a 
     study submission. If the Agency determines that the 
     deficiencies are substantial or new substantial information 
     is provided, the Agency will review and act on 90 percent of 
     resubmitted JINAD study submissions within 180 days after the 
     receipt date of a complete study submission.
       6. JINAD Protocols
       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 75 days after the 
     submission date.
       Allow comparability protocols as described in 21 CFR 
     514.8(b)(2)(v) to be submitted as protocols without 
     substantial data in a JINAD file. The Agency will review and 
     act on 90 percent of JINAD submissions consisting of 
     protocols without substantial data within 75 days after the 
     submission date of the protocol. For potentially more complex 
     comparability protocols, for example sterile process 
     validation protocols, the sponsor should discuss and have 
     Agency concurrence regarding the appropriate filing strategy.
       7. Request to Establish a JINAD File
       Review and act on 90 percent of original submissions 
     requesting establishment of a JINAD file, within 100 days 
     after the submission date.
       For the application/submission goals above, the term 
     ``review and act on'' means the issuance of either: (1) a 
     complete action letter that approves an original or 
     supplemental ANADA or notifies a sponsor that a JINAD 
     submission is complete or that a JINAD file has been 
     established; or (2) an ``incomplete letter'' that sets forth 
     in detail the specific deficiencies in an 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, filing, or complete submission. Within 30 days of 
     receipt of the application, FDA shall refuse to file an 
     original or supplemental ANADA, or their reactivation, that 
     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 S5043]]

     Within 60 days of receipt of the submission, FDA will refuse 
     to review a JINAD submission that 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. 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 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 (human or animal) health concerns unrecognized at the 
     time of protocol assessment under this process are evident.
       The term ``submission date'' means the date the FDA Center 
     for Veterinary Medicine (CVM) Electronic Submission System 
     (ESS) receives an application or submission. Upon receipt of 
     an application or submission, the CVM ESS creates an 
     electronic receipt that contains the date of receipt and is 
     sent to the submitter.


                      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 will be reviewed with 
     the highest possible priority among those pending.


             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, 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-initiated 
     amendment or incomplete letter; and
       2. The amended information must not significantly change 
     the similar applications or submissions; 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 the similar 
     original ANADA, manufacturing supplemental ANADA; or
       b. 100 days after the submission date for the similar JINAD 
     study submissions; or
       c. 40 days after the submission date for the similar JINAD 
     protocol submissions.
       If the Agency determines that the above criteria have been 
     met, it will not change the user fee goal for the similar 
     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 similar application or submission 
     resubmitted on the date of the sponsor-initiated amendment, 
     thereby resetting the clock to the date FDA received the 
     amendment.


Multiple Data Submissions to the Chemistry, Manufacturing, and Controls 
                           Technical Section

       The Agency will continue to allow two-phased Chemistry, 
     Manufacturing, and Controls technical section submissions 
     under the JINAD process.


                Timely Foreign Pre-Approval 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 specified in an 
     abbreviated application, supplemental abbreviated 
     application, or generic investigational file and may be 
     subject to foreign PAIs for the following fiscal year; and 2) 
     a notification 30 days prior to submitting an abbreviated 
     application, a supplemental abbreviated application, or 
     generic investigational file 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 abbreviated 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.


                        Foreign GMP Inspections

       The Agency commits to exploration and implementation of the 
     United States and European Union and the United States and 
     United Kingdom Good Manufacturing Practice Mutual Inspection 
     Agreement and future Mutual Recognition Agreements, with 
     respect to generic new animal drug products subject to 
     review, starting in FY 2024 for establishments manufacturing 
     animal/veterinary drugs. The Agency will provide annual 
     progress updates to the industry.


                     Timely Meetings with Industry

       The Agency and the regulated industry agree that the use of 
     both formal meetings (e.g., presubmission conferences, 
     workshops) and informal communication by both parties is 
     critical to ensure high submission quality such that the 
     above performance goals can be achieved.


                   Transparency in the Review Process

     Bioequivalence Technical Section meeting process
       The Agency will enhance transparency by establishing the 
     Bioequivalence Technical Section (BETS) meeting process. The 
     term ``Bioequivalence Technical Section (BETS) meeting'' 
     means an optional meeting for a sponsor seeking further 
     discussion with the Agency after their receipt of CVM's 
     response to their submission of bioequivalence study data in 
     support of their ANADA.
       The formalized process is the following: Once CVM receives 
     a bioequivalence technical section with study data for 
     review, CVM will schedule the BETS meeting for a date 
     approximately one month after the date CVM's review of the 
     technical section is due. The sponsor is expected to submit a 
     detailed list of questions to CVM by email no later than two 
     weeks prior to the BETS meeting date to facilitate 
     preparation for the discussion. The BETS meeting will be a 
     virtual meeting and will include the CVM scientific reviewer 
     and CVM team leader to whom the submission has been assigned 
     for review. CVM will not generate any formal documents after 
     a BETS meeting (e.g., a memorandum of conference).
     Response to request to establish a JINAD file
       When a sponsor submits a request to establish a JINAD file, 
     the Agency will include in its response information 
     describing its current thinking regarding specific elements 
     for inclusion in the Chemistry, Manufacturing, and Controls 
     technical section for the dosage form proposed. The response 
     will list relevant guidance, regulations, and compendial 
     expectations relevant to that dosage form.


                          Workload Adjustment

       For purposes of calculating the workload adjustment, it has 
     been agreed to reset the base years to a rolling average 
     comprising the most recent 5-year completed fiscal years. For 
     example, beginning October 1, 2024 (FY 2025), the base will 
     comprise Fiscal Years 2019 through 2023. At the start of each 
     fiscal year thereafter, the base will be adjusted upward by 
     one year on the upper and lower ends of the range. There will 
     be no workload adjustment for FY 2024. Workload adjustments 
     are one-time adjustments, and are calculated annually. The 
     percent increase in fees will be made if the amount of the 
     workload adjuster is equal to or greater than one percent 
     (1%). The weighting factor is the percent of direct review 
     time spent on each of the six component submission types over 
     the most recent five-year period.

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