[Congressional Record Volume 153, Number 148 (Tuesday, October 2, 2007)]
[Senate]
[Pages S12421-S12428]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




PERFORMANCE GOALS FOR THE PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

  Mr. Kennedy. Mr. President, on September 20, 2007, the Senate passed 
H.R. 3580, the Food and Drug Administration Amendments Act of 2007. 
Title I of this bill is the reauthorization of the FDA's prescription 
drug user fee program, and includes the initial authorization for a 
voluntary user fee program for advisory reviews of direct-to-consumer 
television advertising.
  Performance goals, existing outside of the statute, accompany the 
reauthorization of the drug user fee program and the authorization of 
the advisory review user fee program. These goals represent a realistic 
projection of what the Food and Drug Administration's Center for Drug 
Evaluation and Research and Center for Biologics Evaluation and 
Research 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 a document with two sections entitled ``PDUFA REAUTHORIZATION 
PERFORMANCE GOALS AND PROCEDURES'' and ``PERFORMANCE GOALS AND 
PROCEDURES FOR ADVISORY REVIEW OF DIRECT-TO-CONSUMER TELEVISION 
ADVERTISING.'' According to Section 101(c) of H.R. 3580, ``the fees 
authorized by the amendments made in this title will

[[Page S12422]]

be dedicated toward expediting the drug development process and the 
process for the review of human drug applications, including postmarket 
drug safety activities, as set forth in the goals . . .in the letters 
from the Secretary of Health and Human Services to the Chairman of the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Chairman of the Committee on Energy and Commerce of the House of 
Representatives, 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 
September 27, 2007, as well as the letter from Secretary Leavitt that 
accompanied the transmittal of this document.
  The agency-industry agreement on prescription drug user fees 
includes, for each of the 5 fiscal years of the reauthorization, an 
additional $29,290,000 and 82 full time employees for the postmarket 
drug safety activities described in the document. These funds are 
augmented in Title I of H.R. 3580 by an additional $225 million for 
postmarket drug safety, $25 million for fiscal year 2008, $35 million 
for fiscal year 2009, $45 million for fiscal year 2009, $55 million for 
fiscal year 2010, and $65 million for fiscal year 2011. The FDA will 
use this $225 million to implement the postmarket drug safety programs 
and authorities set out in Title IX of H.R. 3580.
  I ask unanimous consent this material be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                    Health and Human Services,

                               Washington, DC, September 27, 2007.
     Edward M. Kennedy,
     Chairman, Committee on Health, Education, Labor, and 
         Pensions, U.S. Senate, Washington, DC.
       Dear Chairman Kennedy: I want to congratulate you for 
     completing action on the FDA Amendments Act, H.R. 3580. As 
     you know, this bill contains the reauthorization of user fees 
     for drugs and devices as well as other key provisions vital 
     to the Food and Drug Administration. We appreciate your 
     support and hard work on this legislation, the commitment of 
     Members of the Committee in working out these measures, and 
     the support shown by the full Senate.
       I am including as enclosures to this letter the two 
     commitment documents for the drug and device user fee 
     programs which outline the agreements between the Agency and 
     the industries with regard to application approval 
     timeframes, issuance of guidances, post market program 
     enhancements, and milestones for other activities to be 
     supported by user fees. These documents cover fiscal years 
     2008 through 2012 and they represent the commitment of the 
     Department and the FDA to carry out the goals under the 
     mutual agreement with the industries.
       Thank you again for successful enactment of the FDA 
     Amendments Act. I look forward to working with you as we 
     proceed with the implementation of this legislation.
           Sincerely,
                                               Michael O. Leavitt,
     Secretary.
                                  ____


   Section A: PDUFA Reauthorization Performance Goals and Procedures 
                     Fiscal Years 2008 Through 2012

       The performance goals and procedures of the FDA Center for 
     Drug Evaluation and Research (CDER) and the Center for 
     Biologics Evaluation and Research (CBER), as agreed to under 
     the reauthorization of the prescription drug user fee program 
     in the [cite statute] are summarized below.
       Unless otherwise stated, goals apply to cohorts of each 
     fiscal year (FY).
       I. REVIEW PERFORMANCE GOALS
       A. NDA/BLA Submissions and Resubmissions
       1. Review and act on 90 percent of standard original NDA 
     and BLA submissions within 10 months of receipt.
       2. Review and act on 90 percent of priority original NDA 
     and BLA submissions within 6 months of receipt.
       3. Review and act on 90 percent of Class 1 resubmitted 
     original applications within 2 months of receipt.
       4. Review and act on 90 percent of Class 2 resubmitted 
     original applications within 6 months of receipt.
       B. Original Efficacy Supplements
       1. Review and act on 90 percent of standard efficacy 
     supplements within 10 months of receipt.
       2. Review and act on 90 percent of priority efficacy 
     supplement within 6 months of receipt.
       C. Resubmitted Efficacy Supplements
       1. Review and act on 90 percent of Class 1 resubmitted 
     efficacy supplements within 2 months of receipt.
       2. Review and act on 90 percent of Class 2 resubmitted 
     efficacy supplements within 6 months of receipt.
       D. Original Manufacturing Supplements
       1. Review and act on 90 percent of manufacturing 
     supplements within 6 months of receipt and review and act on 
     90 percent of manufacturing supplements requiring prior 
     approval within 4 months of receipt.
       E. These review goals are summarized in the following 
     table:

       ORIGINAL AND RESUBMITTED NDAs/BLAs AND EFFICACY SUPPLEMENTS
------------------------------------------------------------------------
       Submission cohort              Standard             Priority
------------------------------------------------------------------------
Original Applications..........  90% in 10 Mo......  90% in 6 Mo.
Class 1 Resubmissions..........  90% in 2 Mo.......  90% in 2 Mo.
Class 2 Resubmissions..........  90% In 6 Mo.......  90% in 6 Mo.
Original Efficacy Supplements..  90% in 10 Mo......  90% in 6 Mo.
Class 1 Resubmitted Efficacy     90% in 2 Mo.......  90% in 2 Mo.
 Supplements.
Class 2........................  90% in 6 Mo.......  90% in 6 Mo.
 
                        MANUFACTURING SUPPLEMENTS
 
FY 2008-2012...................  90% in 6 Mo.......  90% in 4 Mo.
------------------------------------------------------------------------

       II. NEW MOLECULAR ENTITY (NME) PERFORMANCE GOALS
       A. The performance goals for standard and priority original 
     NMEs in each submission cohort will be the same as for all of 
     the original NDAs (including NMEs) in each submission cohort 
     but shall be reported separately.
       B. For biological products, for purposes of this 
     performance goal, all original BLAs will be considered to be 
     NMEs.
       III. MEETING MANAGEMENT GOALS
       A. Responses to Meeting Requests
       1. Procedure: Within 14 calendar days of the Agency's 
     receipt of a request from industry for a formal Type A 
     meeting, or within 21 calendar days of the Agency's receipt 
     of a request from industry for a formal Type B or Type C 
     meeting (i.e., a scheduled face-to-face, teleconference, or 
     videoconference), CBER and CDER should notify the requester 
     in writing (letter or fax) of the date, time, and place for 
     the meeting, as well as expected Center participants.
       2. Performance Goal: FDA will provide this notification 
     within 14 days for 90% of Type A meeting requests and within 
     21 days for 90% of Type B and Type C meeting requests.
       B. Scheduling Meetings
       1. Procedure: The meeting date should reflect the next 
     available date on which all applicable Center personnel are 
     available to attend, consistent with the component's other 
     business; however, the meeting should be scheduled consistent 
     with the type of meeting requested. If the requested date for 
     any of these types of meetings is greater than 30, 60, or 75 
     calendar days (as appropriate) from the date the request is 
     received by the Agency, the meeting date should be within 14 
     calendar days of the date requested.
       a) Type A Meetings should occur within 30 calendar days of 
     the Agency receipt of the meeting request.
       b) Type B Meetings should occur within 60 calendar days of 
     the Agency receipt of the meeting request.
       c) Type C Meetings should occur within 75 calendar days of 
     the Agency receipt of the meeting request.
       2. Performance goal: 90% of meetings are held within the 
     timeframe.
       C. Meeting Minutes
       1. Procedure: The Agency will prepare minutes which will be 
     available to the sponsor 30 calendar days after the meeting. 
     The minutes will clearly outline the important agreements, 
     disagreements, issues for further discussion, and action 
     items from the meeting in bulleted form and need not be in 
     great detail.
       2. Performance goal: 90% of minutes are issued within 30 
     calendar days of date of meeting.
       D. Conditions
       For a meeting to qualify for these performance goals:
       1. A written request (letter or fax) should be submitted to 
     the review division; and
       2. The letter should provide:
       a) A brief statement of the purpose of the meeting;
       b) A listing of the specific objectives/outcomes the 
     requester expects from the meeting;
       c) A proposed agenda, including estimated times needed for 
     each agenda item;
       d) A listing of planned external attendees;
       e) A listing of requested participants/disciplines 
     representative(s) from the Center;
       f) The approximate time that supporting documentation 
     (i.e., the ``backgrounder'') for the meeting will be sent to 
     the Center (i.e., ``x'' weeks prior to the meeting, but 
     should be received by the Center at least 2 weeks in advance 
     of the scheduled meeting for Type A meetings and at least 1 
     month in advance of the scheduled meeting for Type B and Type 
     C meetings); and
       3. The Agency concurs that the meeting will serve a useful 
     purpose (i.e., it is not premature or clearly unnecessary). 
     However, requests for a ``Type B'' meeting will be honored 
     except in the most unusual circumstances.

[[Page S12423]]

       Sponsors are encouraged to consult available FDA guidance 
     to obtain further information on recommended meeting 
     procedures.
       IV. CLINICAL HOLDS
       A. Procedure: The Center should respond to a sponsor's 
     complete response to a clinical hold within 30 days of the 
     Agency's receipt of the submission of such sponsor response.
       B. Performance goal: 90% of such responses are provided 
     within 30 calendar days of the Agency's receipt of the 
     sponsor's response.
       V. MAJOR DISPUTE RESOLUTION
       A. Procedure: For procedural or scientific matters 
     involving the review of human drug applications and 
     supplements (as defined in PDUFA) that cannot be resolved at 
     the signatory authority level (including a request for 
     reconsideration by the signatory authority after reviewing 
     any materials that are planned to be forwarded with an appeal 
     to the next level), the response to appeals of decisions will 
     occur within 30 calendar days of the Center's receipt of the 
     written appeal.
       B. Performance goal: 90% of such answers are provided 
     within 30 calendar days of the Center's receipt of the 
     written appeal.
       C. Conditions:
       1. Sponsors should first try to resolve the procedural or 
     scientific issue at the signatory authority level. If it 
     cannot be resolved at that level, it should be appealed to 
     the next higher organizational level (with a copy to the 
     signatory authority) and then, if necessary, to the next 
     higher organizational level.
       2. Responses should be either verbal (followed by a written 
     confirmation within 14 calendar days of the verbal 
     notification) or written and should ordinarily be to either 
     grant or deny the appeal.
       3. If the decision is to deny the appeal, the response 
     should include reasons for the denial and any actions the 
     sponsor might take in order to persuade the Agency to reverse 
     its decision.
       4. In some cases, further data or further input from others 
     might be needed to reach a decision on the appeal. In these 
     cases, the ``response'' should be the plan for obtaining that 
     information (e.g., requesting further information from the 
     sponsor, scheduling a meeting with the sponsor, scheduling 
     the issue for discussion at the next scheduled available 
     advisory committee).
       5. In these cases, once the required information is 
     received by the Agency (including any advice from an advisory 
     committee), the person to whom the appeal was made, again has 
     30 calendar days from the receipt of the required information 
     in which to either deny or grant the appeal.
       6. Again, if the decision is to deny the appeal, the 
     response should include the reasons for the denial and any 
     actions the sponsor might take in order to persuade the 
     Agency to reverse its decision.
       7. N.B. If the Agency decides to present the issue to an 
     advisory committee and there are not 30 days before the next 
     scheduled advisory committee, the issue will be presented at 
     the following scheduled committee meeting in order to allow 
     conformance with advisory committee administrative 
     procedures.
       VI. SPECIAL PROTOCOL QUESTION ASSESSMENT AND AGREEMENT
       A. Procedure: Upon specific request by a sponsor (including 
     specific questions that the sponsor desires to be answered), 
     the Agency will evaluate certain protocols and issues to 
     assess whether the design is adequate to meet scientific and 
     regulatory requirements identified by the sponsor.
       1. The sponsor should submit a limited number of specific 
     questions about the protocol design and scientific and 
     regulatory requirements for which the sponsor seeks agreement 
     (e.g., is the dose range in the carcinogenicity study 
     adequate, considering the intended clinical dosage; are the 
     clinical endpoints adequate to support a specific efficacy 
     claim).
       2. Within 45 days of Agency receipt of the protocol and 
     specific questions, the Agency will provide a written 
     response to the sponsor that includes a succinct assessment 
     of the protocol and answers to the questions posed by the 
     sponsor. If the Agency does not agree that the protocol 
     design, execution plans, and data analyses are adequate to 
     achieve the goals of the sponsor, the reasons for the 
     disagreement will be explained in the response.
       3. Protocols that qualify for this program include: 
     carcinogenicity protocols, stability protocols, and Phase 3 
     protocols for clinical trials that will form the primary 
     basis of an efficacy claim. (For such Phase 3 protocols to 
     qualify for this comprehensive protocol assessment, the 
     sponsor must have had an end of Phase 2/pre-Phase 3 meeting 
     with the review division so that the division is aware of the 
     developmental context in which the protocol is being reviewed 
     and the questions being answered.)
       4. N.B. For products that will be using Subpart E or 
     Subpart H development schemes, the Phase 3 protocols 
     mentioned in this paragraph should be construed to mean those 
     protocols for trials that will form the primary basis of an 
     efficacy claim no matter what phase of drug development in 
     which they happen to be conducted.
       5. If a protocol is reviewed under the process outlined 
     above and agreement with the Agency is reached on design, 
     execution, and analyses and if the results of the trial 
     conducted under the protocol substantiate the hypothesis of 
     the protocol, the Agency agrees that the data from the 
     protocol can be used as part of the primary basis for 
     approval of the product. The fundamental agreement here is 
     that having agreed to the design, execution, and analyses 
     proposed in protocols reviewed under this process, the Agency 
     will not later alter its perspective on the issues of design, 
     execution, or analyses unless public health concerns 
     unrecognized at the time of protocol assessment under this 
     process are evident.
       B. Performance goal: 90% of special protocols assessments 
     and agreement requests completed and returned to sponsor 
     within timeframes.
       C. Reporting: The Agency will track and report the number 
     of original special protocol assessments and resubmissions 
     per original special protocol assessment.
       VII. ADDITIONAL PROCEDURES
       A. Simplification of Action Letters
       To simplify regulatory procedures, CBER and CDER intend to 
     amend their regulations and processes to provide for the 
     issuance of either an ``approval'' (AP) or a ``complete 
     response'' (CR) action letter at the completion of a review 
     cycle for a marketing application.
       B. Timing of Sponsor Notification of Deficiencies in 
     Applications
       To help expedite the development of drug and biologic 
     products, CBER and CDER intend to submit deficiencies to 
     sponsors in the form of a ``discipline review'' (DR) letter 
     when each discipline has finished its initial review of its 
     section of the pending application.
       VIII. ENHANCEMENT AND MODERNIZATION OF THE FDA DRUG SAFETY 
     SYSTEM
       FDA will use user fees to enhance and modernize the current 
     U.S. drug safety system. FDA will adopt new scientific 
     approaches, improve the utility of existing tools for the 
     detection, evaluation, prevention, and mitigation of adverse 
     events, and continue to enhance and improve communication and 
     coordination between post-market and pre-market review staff. 
     Enhancements to the post-market drug safety system will 
     improve the public health by increasing patient protection 
     while continuing to enable access to needed medical products. 
     User fees will provide support for 1) preparing and 
     implementing a 5-year plan to modernize drug safety, 
     including improving communication and coordination between 
     the post-market and pre-market review staff, 2) conducting 
     and/or supporting activities designed to modernize the 
     process of pharmaco-vigilance, 3) developing with sponsors, 
     reviewing, and monitoring implementation of risk management 
     plans, and 4) related activities.
       A. Development of 5-year plan, and Communications and 
     Technical Interactions
       1. The FDA will develop and periodically update a 5-year 
     plan describing activities that will lead to enhancing and 
     modernizing FDA's drug safety activities/system. The 
     activities described in the 5-year plan will include:
       a) Assessment of current and new methodologies to maximize 
     the public health benefit associated with collecting adverse 
     event information at various points during the product 
     lifecycle;
       b) With input from academia, industry, and others from the 
     general public, identifying epidemiology best practices and 
     developing guidance(s) describing these practices;
       c) Expanding CBER/CDER's database acquisition and use for 
     the purposes of targeted post-marketing surveillance and 
     epidemiology;
       d) Developing and validating risk management and risk 
     communication tools, including assessing the effectiveness of 
     risk management plan agreements and developing, implementing, 
     and evaluating mechanisms for public communications about the 
     benefits and risks of drugs and biological products;
       e) Improving post-market IT systems (e.g., AERS 2, safety 
     tracking system, and opportunities for linked data 
     management);
       f) Enhancing and improving communication and coordination 
     between the Office of Surveillance and Epidemiology and the 
     Office of New Drugs in CDER and the Office of Biostatistics 
     and Epidemiology and the pre-market product review Offices in 
     CBER, including activities to assess the impact and value of 
     routinely including post-market review staff on pre-market 
     review teams.
       2. The plan will be drafted, published on the FDA website, 
     and updated as follows:
       a) FDA will publish a draft of the plan by March 31, 2008. 
     At that time, FDA will solicit and consider comments from the 
     public on the draft plan. The public comment period will be 
     at least 45 calendar days. FDA will complete revisions to the 
     plan and publish the final version no later than December 31, 
     2008.
       b) By the end of FY 09, FDA will conduct an annual 
     assessment of progress against the plan to be published on 
     the FDA website. The report will describe progress on issues 
     outlined in the five year plan. In addition, the report will 
     include FDA efforts to facilitate the interactions between 
     OND/OSE related to the process of evaluating and responding 
     to post-marketing drug safety/adverse event reports.
       c) FDA will publish updates to the plan as FDA deems 
     necessary. FDA will publish on the FDA website draft 
     revisions to the plan, solicit comments from the public on 
     those draft revisions, and consider the public comments 
     before completing and publishing updates to the plan.
       B. Conduct and support activities designed to modernize the 
     process of pharmaco-vigilance
       1. Maximize the Public Health Benefit of Adverse Event (AE) 
     Collection Throughout

[[Page S12424]]

     the Product Life Cycle: By the end of FY 08, FDA will publish 
     a Request for Proposals (RFP) to solicit proposals from 
     outside research organizations to conduct research on 
     determining the best way to maximize the public health 
     benefit associated with collecting and reporting serious and 
     non-serious adverse events occurring throughout a product's 
     life cycle. Central to addressing this question are 
     determining the number and type of safety concerns discovered 
     by AE collection, the age of products at the time safety 
     concerns are detected by AE collection, and the types of 
     actions that are subsequently taken to protect patient 
     safety. Contractor(s) should study adverse event collection 
     both within and outside the U.S. Contract(s) will be awarded 
     during FY 09 and the completion of study(ies) targeted for FY 
     11.
       2. Epidemiology Best Practices and Guidance Document 
     Development: During FY 08, the FDA, with input from academia, 
     industry, and others from the general public, will hold a 
     public workshop to identify epidemiology best practices. The 
     workshop will examine current epidemiology practices both 
     within and outside the U.S. By the end of FY 10, CDER and 
     CBER jointly will develop and issue a draft guidance document 
     that addresses epidemiology best practices and provides 
     guidance on carrying out scientifically sound observational 
     studies using quality data resources. A final guidance will 
     be issued in FY 11.
       3. Expanding Database Resources: A critical part of the 
     transformation of the drug safety program is maximizing the 
     usefulness of tools used for adverse event signal detection 
     and risk assessment. To achieve this end, data other than 
     passive spontaneous reports, including population-based 
     epidemiological data and other types of observational data 
     resources will be used and evaluated. Access to these types 
     of data will expand the FDA's capability to carry out 
     targeted post-marketing surveillance, look at class effects 
     of drugs, and potentially carry out signal detection using 
     data resources other than reports from AERs system. PDUFA 
     funds will be used to obtain access to additional databases, 
     to train existing staff, and to hire additional 
     epidemiologists and programmers to be able to use these new 
     resources.
       4. Development and Validation of Risk Management and Risk 
     Communication Tools: During FY 08, FDA will develop a plan to 
     1) identify, with input from academia, industry, and others 
     from the general public, risk management tools and programs 
     for the purpose of evaluation and 2) conduct assessments of 
     the effectiveness of identified Risk Minimization Action 
     Plans (RiskMAPS) and current risk management and risk 
     communication tools. A public workshop will be held during FY 
     09 to obtain input from industry and other stakeholders 
     regarding the prioritization of the plans and tools to be 
     evaluated. Starting in FY 09, FDA will conduct annual 
     systematic public discussion and review of the effectiveness 
     of one to two risk management program(s) and one major risk 
     management tool. Reports of these discussions will be posted 
     on the FDA website.
       C. Review of risk management plans
       FDA may use user fees for the review of risk management 
     plans and related activities (e.g., meeting with sponsors, 
     collaborations between review divisions and the appropriate 
     safety group in CDER or CBER, and reviews of periodic reports 
     on the implementation of any risk management plan).
       D. Other Activities
       FDA will establish the following standards-based 
     information systems to support how FDA obtains and analyzes 
     post-market drug safety data and manages emerging drug safety 
     information:
       1. Enhanced adverse event reporting system and surveillance 
     tools;
       2. IT infrastructure to support access and analyses of 
     externally-linked databases; and
       3. Workflow tracking system.
       IX. REVIEW OF PROPRIETARY NAMES TO REDUCE MEDICATION ERRORS
       To enhance patient safety, FDA will utilize user fees to 
     implement various measures to reduce medication errors 
     related to look-alike and sound-alike proprietary names and 
     such factors as unclear label abbreviations, acronyms, dose 
     designations, and error prone label and packaging design.
       A. Review Performance Goals--Drug/Biological Product 
     Proprietary Names
       1. Proprietary names submitted during IND phase (as early 
     as end-of-phase 2)
       a) Review 50% of proprietary name submissions filed during 
     FY 09 within 180 days of receipt. Notify sponsor of tentative 
     acceptance or non-acceptance.
       b) Review 70% of proprietary name submissions filed during 
     FY 10 within 180 days of receipt. Notify sponsor of tentative 
     acceptance or non-acceptance.
       c) Review 90% of proprietary name submissions filed during 
     FYs 11 and 12 within 180 days of receipt. Notify sponsor of 
     tentative acceptance or non-acceptance.
       d) If proprietary name is found to be unacceptable, sponsor 
     can request reconsideration by submitting a written rebuttal 
     with supporting data or request a meeting within 60 days to 
     discuss the initial decision (meeting package required).
       e) If proprietary name is found to be unacceptable, the 
     above review performance goals also would apply to the 
     written request for reconsideration with supporting data or 
     the submission of a new proprietary name.
       f) Complete submission is required to begin the review 
     clock.
       2. Proprietary names submitted with NDA/BLA
       a) Review 50% of NDA/BLA proprietary name submissions filed 
     during FY 09 within 90 days of receipt. Notify sponsor of 
     tentative acceptance/non-acceptance.
       b) Review 70% of NDA/BLA proprietary name submissions filed 
     during FY 10 within 90 days of receipt. Notify sponsor of 
     tentative acceptance/non-acceptance.
       c) Review 90% of NDA/BLA proprietary name submissions filed 
     during FYs 11 and 12 within 90 days of receipt. Notify 
     sponsor of tentative acceptance/non-acceptance.
       d) A supplemental review will be done meeting the above 
     review performance goals if the proprietary name has been 
     submitted previously (IND phase after end of phase 2) and has 
     received tentative acceptance.
       e) If proprietary name is found to be unacceptable, sponsor 
     can request reconsideration by submitting a written rebuttal 
     with supporting data or request a meeting within 60 days to 
     discuss the initial decision (meeting package required).
       f) If proprietary name is found to be unacceptable, the 
     above review performance goals apply to the written request 
     for reconsideration with supporting data or the submission of 
     a new proprietary name.
       g) Complete submission is required to begin the review 
     clock.
       3. Guidance Document Development
       a) By the end of FY 08, FDA will publish a final guidance 
     on the contents of a complete submission package for a 
     proposed proprietary drug/biological product name.
       b) By the end of FY 09, FDA will prepare a MaPP (Manual of 
     Policies and Procedures) to ensure that FDA internal 
     processes (e.g., Division of Medication Errors and Technical 
     Support, Division of Drug Marketing, Advertising, and 
     Communications, Office of New Drugs, CDER and Advertising and 
     Promotional Labeling Branch, CBER) are consistent with 
     meeting the proprietary name review goals.
       c) By the end of FY 10, after public consultation with 
     academia, industry, and others from the general public, FDA 
     will publish a draft guidance on best practices for naming, 
     labeling and packaging drugs and biologics to reduce 
     medication errors. Final guidance will be published by the 
     end of FY 11.
       d) By the end of FY 12, after public consultation with 
     industry, academia and others from the general public, FDA 
     will publish a draft guidance on proprietary name evaluation 
     best practices. Publication of final guidance on proprietary 
     name evaluation best practices will follow as soon as 
     feasible.
       B. Pilot Program
       During PDUFA IV, FDA will develop and implement a pilot 
     program to enable pharmaceutical firms participating in the 
     pilot to evaluate proposed proprietary names and submit the 
     data generated from those evaluations to the FDA for review.
       1. FDA will hold a public technical meeting to discuss the 
     elements necessary to create a concept paper describing the 
     logistics of the pilot program, the contents of a proprietary 
     name review submission, and the criteria to be used by FDA to 
     review submissions under the pilot program. Subsequently, by 
     the end of FY 08, FDA will publish the concept paper.
       2. By the end of FY 09, FDA will begin enrollment into the 
     pilot program.
       3. By the end of FY 11, or subsequent to accruing two years 
     of experience with pilot submissions, FDA will evaluate the 
     pilot program.
       C. Other Activities
       1. FDA and industry are interested in exploring the 
     possibility of ``reserving'' proprietary names for companies 
     once the names have been tentatively accepted by the Agency. 
     By the end of FY 08, FDA will initiate a public process to 
     discuss issues around ``reserving'' proprietary names.
       2. FDA will provide the full source code and supporting 
     technical documentation for the Phonetic and Orthographic 
     Computer Analysis (POCA) tool and make it available on disk 
     for use by industry and others from the general public by 
     end of FY 08.
       X. FIRST CYCLE REVIEW PERFORMANCE PROPOSAL
       A. Notification of Issues Identified during the Filing 
     Review
       1. Performance Goal: For original NDA/BLA applications and 
     efficacy supplements, FDA will report substantive review 
     issues identified during the initial filing review to the 
     applicant by letter, telephone conference, facsimile, secure 
     e-mail, or other expedient means.
       2. The timeline for such communication will be within 14 
     calendar days after the 60-day filing date.
       3. If no substantive review issues were identified during 
     the filing review, FDA will so notify the applicant.
       4. FDA's filing review represents a preliminary review of 
     the application and is not indicative of deficiencies that 
     may be identified later in the review cycle.
       5. FDA will notify the applicant of substantive review 
     issues prior to the goal date for 90% of applications.
       B. Notification of Planned Review Timelines
       1. Performance Goal: For original NDA/BLA applications and 
     efficacy supplements, FDA will inform the applicant of the 
     planned timeline for review of the application. The 
     information conveyed will include a target date for 
     communication of feedback from the review division to the 
     applicant regarding proposed labeling and postmarketing study 
     commitments (PMCs) the Agency will be requesting.
       2. The planned review timeline will be included with the 
     notification of issues identified during the filing review, 
     within 14 calendar days after the 60-day filing date.

[[Page S12425]]

       3. The planned review timelines will be consistent with the 
     Guidance for Review Staff and Industry: Good Review 
     Management Principles and Practices for PDUFA Products 
     (GRMPs), taking into consideration the specific circumstances 
     surrounding the individual application.
       4. The planned review timeline will be based on the 
     application as submitted.
       5. FDA will inform the applicant of the planned review 
     timeline for 90% of original BLA and NME NDA applications 
     beginning in FY 09; 90% of efficacy supplements for new or 
     expanded indications beginning in FY 10; 90% of all original 
     NDAs/BLAs beginning in FY 11; and 90% of all efficacy 
     supplements beginning in FY 12 (see table below).

                                                    (Percent)
----------------------------------------------------------------------------------------------------------------
                                                                      FY 08    FY 09    FY 10    FY 11    FY 12
----------------------------------------------------------------------------------------------------------------
Original BLAs and NME NDAs.........................................       --       90       90       90       90
Efficacy supplements for new/expanded indications..................       --       --       90       90       90
All original NDAs..................................................       --       --       --       90       90
All efficacy supplements...........................................       --       --       --       --       90
----------------------------------------------------------------------------------------------------------------

       6. Should the applicant submit any unsolicited major 
     amendment(s) to the application (e.g., a major new clinical 
     safety/efficacy study report, major re-analyses of previously 
     submitted study(ies)) and if the division chooses to review 
     such amendment(s) during that review cycle, the planned 
     review timeline will no longer be applicable (even if the 
     unsolicited major amendment leads to an extension of the 
     overall PDUFA review clock). No new planned review timeline 
     need be provided in such cases; however, the overall PDUFA 
     action goal date, including any extension, will still apply. 
     The division will notify the applicant promptly of its 
     decision regarding review of the unsolicited major 
     amendment(s) and whether the planned review timeline is still 
     applicable.
       7. In the event FDA determines that significant 
     deficiencies in the application preclude discussion of 
     labeling or PMCs by the target date identified in the planned 
     review timeline (e.g., failure to demonstrate efficacy, 
     significant safety concern(s), need for a new study(ies) or 
     extensive re-analyses of existing data before approval), FDA 
     will communicate this determination to the applicant in 
     accordance with GRMP and no later than the target date. In 
     such cases the planned review timeline will be considered to 
     have been met. Communication of FDA's determination may occur 
     by letter, telephone conference, facsimile, secure e-mail, or 
     other expedient means. Communication of the deficiencies 
     identified will generally occur through issuance of a 
     discipline review letter(s) in advance of the planned target 
     date for initiation of postmarketing study commitments and 
     labeling discussions.
       8. Should the applicant submit a major amendment(s) (e.g., 
     a major new clinical safety/efficacy study report, major re-
     analyses of previously submitted study(ies)) to provide 
     information or data requested by FDA during the review (e.g., 
     a solicited major amendment) and if the division chooses to 
     review such amendment(s) during that review cycle, the 
     planned review timeline initially communicated will generally 
     no longer be applicable. If the solicited major amendment 
     does not result in an extension of the overall PDUFA review 
     clock, and depending upon the circumstances, the review 
     division may choose to retain the previously communicated 
     planned review timeline (e.g., the solicited major amendment 
     is submitted early in the review cycle, review of the 
     amendment is not expected to significantly alter the 
     division's planned review timeline). If the solicited major 
     amendment is submitted during the last 90 days of the review 
     cycle and results in an extension of the PDUFA action date 
     (review clock), the review division will establish a new 
     review timeline for communication of feedback on proposed 
     labeling and PMCs. The division will notify the applicant 
     promptly of its decision regarding review of the major 
     amendment(s) and whether the planned review timeline is still 
     applicable. If the solicited major amendment results in an 
     extension of the overall PDUFA review clock, the division 
     will communicate a new planned review timeline to the 
     applicant at the time of the clock extension.
       C. Report on Review Timeline Performance
       1. FDA will report its performance in meeting the goals for 
     inclusion of a planned review timeline with the notification 
     of issues identified during the filing review in the annual 
     PDUFA performance report.
       2. FDA will report its performance in meeting the planned 
     review timeline for communication of labeling comments and 
     PMC requests in the annual PDUFA performance report. The 
     report will include the percentage of applications for which 
     the planned target dates for communication of labeling 
     comments and PMC requests were met. The report will also note 
     how often the planned review timeline was met based on 
     communication of labeling comments and PMC requests by the 
     target date and how often such communication did not occur 
     due to FDA's determination that significant deficiencies in 
     the application precluded communication of labeling comments 
     and PMC requests at the time initially projected. 
     Communication of labeling comments and PMC requests, or 
     communication of FDA's determination that significant 
     deficiencies preclude initiation of such discussions, within 
     7 calendar days of the target date stated in the planned 
     review timeline will be considered to have met the target 
     date. FDA will also report the number of times that the 
     review timelines were inapplicable due to the Agency's 
     decision to review an unsolicited major amendment or a 
     solicited major amendment that did not result in an extension 
     of the review clock (unless the review division chose to 
     retain the previously communicated planned review timeline.)
       3. FDA will engage an independent outside consultant to 
     conduct an analysis of the Agency's success in adhering to 
     the planned review timelines. The contractor will assess the 
     factors, based on input from both the FDA and the applicants, 
     that contributed to the ability of the Agency to adhere to 
     the planned review timelines and those factors attributable 
     to either the FDA or the applicant that contributed to 
     failure to adhere to the planned review timeline. A final 
     report will be provided to FDA at least 6 months before the 
     end of FY 11. FDA will make available a releasable version of 
     the final report within 2 months of receipt from the 
     independent outside consultant.
       D. Standard Operating Procedures and Training
       FDA will develop harmonized (CBER/CDER) standard operating 
     procedures (SOPs) regarding the notification of planned 
     review timelines. These SOPs will be finalized and 
     implemented by the end of FY 08. Training will be provided to 
     all CBER and CDER review staff on the harmonized (CBER/CDER) 
     standard operating procedures. Training will continue for all 
     new review staff and refresher training will be provided to 
     all review staff as necessary through FY 12.
       XI. EXPEDITING DRUG DEVELOPMENT
       A. Guidance Development: FDA will develop and publish for 
     comment draft guidances on the following topics by the end of 
     the indicated Fiscal Year of PDUFA-IV. FDA will complete the 
     final guidances within one year of the close of the public 
     comment period.
       1. Clinical Hepatotoxicity--FY 2008
       2. Non-inferiority Trials--FY 2008
       3. Adaptive Trial Designs--FY 2008
       4. End of Phase 2(a) Meetings--FY 2008
       5. Multiple Endpoints in Clinical Trials--FY 2009
       6. Enriched Trial Designs--FY 2010
       7. Imaging Standards for Use as an End Point in Clinical 
     Trials--FY 2011
       B. Ongoing Scientific Collaboration: FDA will participate 
     in workshops with representatives from the scientific 
     community (including industry, academia and other interested 
     stakeholders) to further the science toward development of 
     guidance documents in the following areas:
       1. Predictive Toxicology
       2. Biomarker Qualification
       3. Missing Data
       C. FDA will participate in workshops and other public 
     meetings to explore new approaches to a structured model for 
     benefit/risk assessment. The results of these interactions 
     will be used to assess whether pilot(s) of such new 
     approaches can be conducted during PDUFA-IV. These efforts 
     may lead to the development of guidance documents.
       XII. POSTMARKETING STUDY COMMITMENTS
       FDA will develop harmonized (CBER/CDER) standard operating 
     procedures that articulate the Agency's policy and procedures 
     (e.g., timing, content, rationale and vetting process) for 
     requesting that applicants agree in writing to voluntary 
     postmarketing study commitments. The SOPs will be finalized 
     prior to the end of FY 08. In developing these SOPs, the 
     Agency will take into consideration the findings of the 
     contractor study of current Agency procedures to be completed 
     during FY 07. FDA will make available a releasable version of 
     the final report within 2 months of receipt from the 
     contractor. Training will be provided to all CBER and CDER 
     review staff on the harmonized (CBER/CDER) standard operating 
     procedures. Training will continue for all new review staff 
     and refresher training will be provided to all review staff 
     as necessary through FY 12.
       XIII. IMPROVING FDA PERFORMANCE MANAGEMENT
       A. The studies conducted under this initiative are intended 
     to foster:
       1. Development of programs to improve access to internal 
     and external expertise
       2. Reviewer development programs, particularly as they 
     relate to drug review processes
       3. Advancing science and use of information management 
     tools
       4. Improving both inter- and intra-Center consistency, 
     efficiency, and effectiveness
       5. Improved reporting of management objectives
       6. Increased accountability for use of user fee revenues
       7. Focused investments on improvements in the process of 
     drug review
       8. Improved communication between the FDA and industry
       B. Studies will include:
       1. Assessment of the impact of the electronic submission 
     and review environment on the efficiency and effectiveness of 
     the overall process for the review of human drugs.
       2. Assessment of the progress toward full implementation of 
     Good Review Management Principles, focusing on both FDA 
     reviewer practices and industry sponsor practices affecting 
     successful implementation.
       3. Assessment by an independent accounting firm of the 
     review activity adjustment methodology (as described in 
     section 736(c)(2) that is applied in FY 09 with 
     recommendations for changes, if warranted

[[Page S12426]]

       XIV. INFORMATION TECHNOLOGY GOALS
       A. Objectives
       1. FDA is committed to achieve the long-term goal of an 
     automated standards-based information technology (IT) 
     environment for the exchange, review, and management of 
     information supporting the process for the review of human 
     drug applications throughout the product life cycle. Towards 
     this goal, FDA will work toward the accomplishment of the 
     following objectives by the end of FY 12:
       a) Develop and periodically update an IT plan, as defined 
     in Sections B) and C) below, covering a rolling five-year 
     planning horizon.
       b) Develop, implement, and maintain new information systems 
     consistently across all organizational divisions 
     participating in the process for the review of human drug 
     applications, and in compliance with the IT plan, the FDA's 
     program-wide governance process, the FDA's target enterprise 
     architecture, and with HHS enterprise architecture standards. 
     The consistency of development, implementation, and 
     maintenance of new information systems will be determined by 
     the FDA based on considerations of program efficiency and 
     effectiveness. Emphasis will be placed on the consistency of 
     interactions with regulated parties and other external 
     stakeholders.
       c) Update technical specifications and IT-related guidance 
     documents as necessary to reflect consistent program-wide 
     implementation of new information systems supporting 
     electronic information exchange between FDA and regulated 
     parties and other external stakeholders.
       d) Extend the capability of the secure electronic single 
     point of entry to include two-way transmission of regulatory 
     correspondence.
       e) Establish an automated standards-based regulatory 
     submission and review environment for INDs, NDAs, and BLAs, 
     and their supplements, that enables the following functions 
     over the life cycle of the product:
       (1) Electronic IND, NDA, and BLA submissions received by 
     FDA can be archived to enable retrieval through standardized 
     automated links;
       (2) Electronic IND, NDA, and BLA submissions can include 
     cross-references to previously submitted electronic materials 
     through standardized automated links; and
       (3) Archived electronic IND, NDA, and BLA submissions can 
     be retrieved through standardized automated links.
       f) Establish a system for electronic exchange and 
     management of human drug labeling information in a modular 
     manner (e.g., at the label section level) that is based on 
     FDA standards and that enables revision tracking.
       g) Establish standards-based information systems to support 
     how FDA obtains and analyzes post-market drug safety data and 
     manages emerging drug safety information, as described in 
     Section VIII addressing the enhancement and modernization of 
     the FDA drug safety system.
       B. Communications and Technical Interactions
       1. FDA will develop and periodically update a five-year IT 
     plan for improving the automation of business processes and 
     acquiring and maintaining information systems to achieve the 
     objectives defined above in PDUFA IT Goal A. The plan will 
     include measurable or observable milestones toward 
     achievement of those objectives.
       2. The IT plan will be reviewed and approved through the 
     appropriate FDA governance process to ensure it conforms to 
     the Agency's overall long-term automation strategy.
       3. The IT plan will be drafted, published on the FDA web 
     site, and updated as follows:
       a) FDA will publish a draft of the IT plan by December 31, 
     2007. At that time, FDA will solicit and consider comments 
     from the public on the draft IT plan. The public comment 
     period will be at least 45 calendar days. FDA will complete 
     revisions to the IT plan and publish the final version no 
     later than May 30, 2008.
       b) FDA will conduct an annual assessment of progress 
     against the IT plan and publish on the FDA web site a summary 
     of the assessment within 2 months after the close of each 
     fiscal year.
       c) FDA will publish updates to the IT plan as FDA deems 
     necessary to achieve the objectives defined in PDUFA IT Goal 
     A. FDA will publish on the FDA web site draft revisions to 
     the IT plan; solicit comments from the public on those draft 
     revisions; and consider the public comments before completing 
     and publishing updates to the IT plan.
       4. The FDA and industry stakeholders will meet on a 
     quarterly basis to discuss ongoing implementation of the IT 
     plan, status of IT metrics as available, and potential 
     impacts that future activities may have on stakeholders. 
     These meetings will also be used to discuss potential FDA 
     revisions to the IT plan based on operational experience.
       C. Standards and IT Plan
       The IT plan referenced in PDUFA IT Goal B will provide a 
     vision for FDA standards and technical infrastructure 
     supporting the process for the review of human drug 
     applications and will address the following:
       1. A description of the scope and approach for an 
     evaluation and design of the target enterprise architecture 
     necessary to achieve the objectives defined in PDUFA IT Goal 
     A.
       2. The business processes targeted for automation to 
     achieve business-driven objectives.
       3. Which electronic data standards, including the 
     associated Standards Development Organization, are being 
     considered for adoption or development. (Note: The FDA's 
     process for adopting or developing standards includes the 
     consideration of existing open consensus standards prior to 
     the development of new standards. FDA participates in 
     international Standards Development Organizations and 
     supports global harmonization of data standards through open 
     structured processes.)
       4. Implementation of information systems that are based on 
     the electronic data standards.
       5. Training for system users, stakeholder adoption, and 
     communications for transitioning to new or reengineered 
     information systems supporting the process for the review of 
     human drug applications.
       6. A description of FDA's processes for
       a) evaluating business processes for electronic information 
     exchange between FDA and regulated parties or external 
     stakeholders;
       b) evaluating, adopting or developing electronic data 
     standards for information exchange between FDA and regulated 
     parties or external stakeholders; and
       c) developing, piloting, and deploying information systems 
     that use those standards in supporting the process for the 
     review of human drug applications.
       D. Metrics and Measures
       FDA will measure progress toward achievement of the 
     objectives defined in PDUFA IT Goal A. Measures will include:
       1. The number and percentage of IND, NDA, and BLA 
     submissions received in valid electronic format in compliance 
     with FDA standards, categorized by types of submissions. 
     Increasing the number and percentage of IND, NDA, and BLA 
     submissions received in valid electronic format is a goal 
     that is supported by the FDA and industry stakeholders. 
     Achievement of this goal requires the cooperation of 
     regulated industry. To support the assessment of this goal, 
     the following information will be tracked and reported at 
     least annually:
       a) Total number of submissions categorized by type of 
     submission;
       b) Total number of submissions in valid electronic format 
     in compliance with FDA standards
       c) Total number of submissions received through the secure 
     electronic single point of entry versus other methods; and
       d) Total number of submissions received substantially on 
     paper.
       2. Total number of standards-based electronic submissions 
     that fail to comply with FDA electronic submission standards, 
     along with a distribution of these submission failures across 
     categories of failure or problem type.
       3. Annual spending on maintenance of legacy IT systems and 
     IT systems that are common across the organizational 
     divisions participating in the process for the review of 
     human drug applications.
       4. Other measures and milestones to be identified in the IT 
     plan addressed under Sections B and C above.
       XV. DEFINITIONS AND EXPLANATION OF TERMS
       A. The term ``review and act on'' is understood to mean the 
     issuance of a complete action letter after the complete 
     review of a filed complete application. The action letter, if 
     it is not an approval, will set forth in detail the specific 
     deficiencies and, where appropriate, the actions necessary to 
     place the application in condition for approval.
       B. A major amendment to an original application, efficacy 
     supplement, or resubmission of any of these applications, 
     submitted within three months of a goal date, may extend the 
     goal date by three months. A major amendment to a 
     manufacturing supplement submitted within two months of the 
     goal date extends the goal date by two months. Only one 
     extension can be given per review cycle.
       C. A resubmitted original application is a complete 
     response to an action letter addressing all identified 
     deficiencies.
       D. Class 1 resubmitted applications are applications 
     resubmitted after a complete response letter (or a not 
     approvable or approvable letter) that include the following 
     items only (or combinations of these items):
       1. Final printed labeling
       2. Draft labeling
       3. Safety updates submitted in the same format, including 
     tabulations, as the original safety submission with new data 
     and changes highlighted (except when large amounts of new 
     information including important new adverse experiences not 
     previously reported with the product are presented in the 
     resubmission)
       4. Stability updates to support provisional or final dating 
     periods
       5. Commitments to perform Phase 4 studies, including 
     proposals for such studies
       6. Assay validation data
       7. Final release testing on the last 1-2 lots used to 
     support approval
       8. A minor reanalysis of data previously submitted to the 
     application (determined * * *
       9. Other minor clarifying information (determined by the 
     Agency as fitting the Class 1 category)
       10. Other specific items may be added later as the Agency 
     gains experience with the scheme and will be communicated via 
     guidance documents to industry.
       E. Class 2 resubmissions are resubmissions that include any 
     other items, including any items that would require 
     presentation to an advisory committee.

[[Page S12427]]

       F. A Type A meeting is a meeting which is necessary for an 
     otherwise stalled drug development program to proceed (a 
     ``critical path'' meeting) or to address an important safety 
     issue.
       G. A Type B Meeting is a 1) pre-IND, 2) end of Phase 1 (for 
     Subpart E or Subpart H or similar products) or end of Phase 
     2/pre-Phase 3, or 3) a pre-NDA/BLA meeting. Each requestor 
     should usually only request 1 each of these Type B meetings 
     for each potential application (NDA/BLA) (or combination of 
     closely related products, i.e., same active ingredient but 
     different dosage forms being developed concurrently).
       H. A Type C meeting is any other type of meeting.
       I. The performance Goals and procedures also apply to 
     original applications and supplements for human drugs 
     initially marketed on an over-the-counter (OTC) basis through 
     an NDA or switched from prescription to OTC status through an 
     NDA or supplement.
       J. IT Definitions (see section XI)
       1. ``Automation of business processes'' refers to the 
     development and deployment of information systems that 
     support program activities (i.e., business processes) 
     conducted under the process for the review of human drug 
     applications. The purpose of business process automation is 
     to support decision making by FDA program managers and 
     reviewers. The scope of business process automation is 
     determined by program managers toward the objective of more 
     efficient and effective program operations.
       2. ``Program'' refers to the organizational resources, 
     procedures, and activities assigned to conduct ``the process 
     for the review of human drug applications,'' as defined in 
     the Prescription Drug User Fee Act.
       3. ``Standards-based'' means compliant with published 
     specifications that address terminology or information 
     exchange between the FDA and regulated parties or external 
     stakeholders, as adopted by the FDA or other agencies of the 
     federal government, and often based on the publications of 
     national or international Standards Development 
     Organizations.
       4. ``FDA Standards'' means technical specifications that 
     have been adopted and published by the FDA through the 
     appropriate governance process. FDA standards may apply to 
     terminology, information exchange, engineering or technology 
     specifications, or other technical matters related to 
     information systems. FDA standards often are based on the 
     publications of other federal agencies, or the publications 
     of national or international Standards Development 
     Organizations.
       5. ``Product life cycle'' means the sequential stages of 
     human drug development, regulatory review and approval, post-
     market surveillance and risk management, and where 
     applicable, withdrawal of an approved drug from the market. 
     In the context of the process for the review of human drug 
     applications, the product life cycle begins with the earliest 
     regulatory submissions in the Investigational New Drug (IND) 
     phase, continues through the New Drug Application (NDA) or 
     Biological Licensing Application (BLA) review phase, and 
     includes post-market surveillance and risk management 
     activities as covered under the process for the review of 
     human drug applications.
       6. ``The FDA's program-wide IT governance process'' 
     includes centralized oversight of all data and technology 
     standards adoption, technology acquisition, and funding 
     allocation.
       7. ``The FDA's target enterprise architecture'' includes 
     data and technology standards for the electronic exchange and 
     management of information supporting the process for the 
     review of human drug applications.

  Section B: Performance Goals and Procedures for Advisory Review of 
  Direct-to-Consumer Television Advertising Fiscal Years 2008 Through 
                                  2012

       The performance goals and procedures of the FDA Center for 
     Drug Evaluation and Research (CDER) and the Center for 
     Biologics Evaluation and Research (CBER), as agreed to under 
     the direct-to-consumer television advertising user fee 
     program in Section 736A of the Federal Food, Drug, and 
     Cosmetic Act are summarized below.
       I. FINDINGS
       A. FDA's advisory review of proposed prescription drug 
     television advertisements helps to ensure that these 
     advertisements communicate information to consumers that is 
     accurate, balanced, and adequately substantiated, thereby 
     improving the quality of these advertisements.
       B. It is important to industry and FDA to provide 
     predictability in the timeframe for reviewing and providing 
     written comments on direct-to-consumer television 
     advertisements submitted to FDA for advisory review before 
     initial dissemination.
       C. FDA needs additional resources to ensure that it has 
     adequate staff to provide advisory reviews of direct-to-
     consumer television advertisements in a timely manner.
       D. A program that requires payment of user fees by those 
     who choose to voluntarily submit direct-to-consumer 
     television advertisements for advisory review by FDA is 
     established to provide needed resources to FDA and improve 
     the timeliness of FDA advisory reviews while maintaining the 
     quality of the reviews.
       E. Each submission for advisory review will be assessed a 
     fee, but the sponsor may resubmit that advertisement one time 
     after receiving comments without further fee assessment.
       F. Under this program, it is important to ensure that FDA 
     has the resources needed to hire and retain adequate staff to 
     meet review performance goals.
       G. Because reviews from this program are dependant on 
     submissions which are unpredictable, the statute establishes 
     a reserve fund to maintain a staff that can meet the review 
     performance goals in case user fees for any year of the 
     program are not adequate. In addition, user fees for all 
     submissions during a fiscal year are to be paid at the start 
     of each fiscal year or late fees will be assessed.
       II. REVIEW PERFORMANCE GOALS
       A. Goals for First 150 Advisory Review Submissions.
       Fiscal Year 2008:
       1. Review and provide advisory comments for 75 original 
     submissions within 45 days (50% of 150).
       2. Review and provide advisory comments for 37 
     resubmissions of original submissions within 30 days (50% of 
     75 resubmissions).
       Fiscal Year 2009:
       1. Review and provide advisory comments for 90 original 
     submissions (60% of 150) within 45 days.
       2. Review and provide advisory comments for 45 
     resubmissions (60% of 75) within 30 days.
       Fiscal Year 2010:
       1. Review and provide advisory comments for 105 original 
     submissions (70% of 150) within 45 days.
       2. Review and provide advisory comments for 52 
     resubmissions (70% of 75) within 30 days.
       Fiscal Year 2011:
       1. Review and provide advisory comments for 120 original 
     submissions (80% of 150) within 45 days.
       2. Review and provide advisory comments for 60 
     resubmissions (80% of 75) within 30 days.
       Fiscal Year 2012:
       1. Review and provide advisory comments for 135 original 
     submissions (90% of 150) within 45 days.
       2. Review and provide advisory comments for 68 
     resubmissions (90% of 75) within 30 days.
       NOTE: For any goal year, if the number of submissions or 
     resubmissions received is not greater than the number for 
     which the Agency has committed to provide advisory comments 
     on within the goal timeframe, then the goal will be to 
     provide comments on 90% of the number received within the 
     goal timeframe. For example, if FDA receives only 30 
     resubmissions in fiscal year 2008, then the goal would be to 
     review 27 resubmissions within 30 days.
       B. Goals after 150 Submissions
       If in any fiscal year after FY 2008, participants in the 
     program indicate (in response to the Federal Register notice) 
     the intent to submit more direct-to-consumer broadcast 
     advertisement submissions for advisory review than were 
     subject to the goals in the prior year, the following 
     performance goals will apply (see Appendix B-1 for specific 
     examples):
       1. In the first year of the increase, FDA will review and 
     provide advisory comments for:
       a) 50% of the additional paid original submissions over the 
     cohort of original submissions from the previous fiscal year, 
     up to a maximum of 50 additional submissions, within 45 days.
       b) 50% of the additional resubmissions over the cohort of 
     resubmissions from the previous fiscal year, up to a maximum 
     of 24 additional resubmissions, within 30 days.
       2. In each subsequent year, the performance goals will 
     increase in the same manner as in section A. for each 
     additional cohort of up to 50 additional submissions over the 
     cohort of the prior year (i.e., in the second year after the 
     increase, the goal will be to review 60% of the additional 
     cohort from the prior year (up to 50 submissions) and 50% of 
     any further additions (up to an additional 50 submissions)).
       3. For purposes of this adjustment, it is assumed that the 
     number of submissions subject to review metrics cannot 
     decrease from one year to the next even if actual submissions 
     decrease.
       4. For purposes of this adjustment, it is assumed that 150 
     submissions are subject to performance goals in fiscal year 
     2008.
       5. The goals described in this subsection will be 
     calculated based solely on the number of submissions 
     identified in response to the Federal Register notice for 
     that fiscal year.
       III. DEFINITIONS AND EXPLANATION OF TERMS
       1. The term ``amendment'' shall mean additional documents 
     submitted to FDA to complete an original submission or 
     resubmission. For example, references that have been cited in 
     the original submission but were omitted from the original 
     submission package could be submitted as an amendment.
       2. The term ``original submission'' shall mean a proposed 
     television advertisement submission for which a sponsor paid 
     for an advisory review. The proposed television advertisement 
     may not be more than two minutes long.
       3. The term ``resubmission'' shall mean a subsequent 
     submission of a revised version of the advertisement 
     contained in an original submission. Any revisions made to 
     the proposed television advertisement must be based on FDA 
     comments on the original submission. The resubmission may not 
     introduce significant new concepts or creative themes into 
     the television advertisement, or

[[Page S12428]]

     FDA will designate it as an original submission. Revisions 
     that require a consult to another division will be considered 
     to introduce ``significant new concepts or creative themes.''

                              Appendix B-1


                    Example 1: Original Submissions

       If participants indicate the intent to submit 150 
     submissions in fiscal year 2008; 200 submissions in fiscal 
     year 2009; 224 submissions in fiscal year 2010; 200 
     submissions in fiscal year 2011; and 250 submissions in 
     fiscal year 2012, the review metrics will be as follows:

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      FY 08: 150 submissions   FY 09: 200 submissions   FY 10: 224 submissions   FY 11: 200 submissions   FY 12: 250 submissions
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Cohort 1 (150 submissions).........................................          75 (50% of 150)          90 (60% of 150)         105 (70% of 150)         120 (80% of 150)         135 (90% of 150)
Cohort 2 (50 submissions)..........................................  .......................           25 (50% of 50)           30 (60% of 50)           35 (70% of 50)           40 (80% of 50)
Cohort 3 (24 submissions)..........................................  .......................  .......................           12 (50% of 24)             0 (60% of 0)           17 (70% of 24)
Cohort 4 (0 submissions)...........................................  .......................  .......................  .......................             0 (50% of 0)             0 (70% of 0)
Cohort 5 (26 submissions)..........................................  .......................  .......................  .......................  .......................           13 (50% of 26)
                                                                    ----------------------------------------------------------------------------------------------------------------------------
    Total Target for 45 Day Review Metric..........................                       75                      115                      147                      155                      205
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                    example 2: original submissions

       If participants indicate the intent to submit 150 
     submissions in fiscal year 2008; 200 submissions in fiscal 
     year 2009; 250 submissions in fiscal year 2010; 300 
     submissions in fiscal year 2011; and 350 submissions in 
     fiscal year 2012, the review metrics will be as follows:

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                                                                      FY 08: 150 submissions   FY 09: 200 submissions   FY 10: 250 submissions   FY 11: 300 submissions   FY 12: 350 submissions
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Cohort 1 (150 submissions).........................................          75 (50% of 150)          90 (60% of 150)         105 (70% of 150)         120 (80% of 150)         135 (90% of 150)
Cohort 2 (50 submissions)..........................................  .......................           25 (50% of 50)           30 (60% of 50)           35 (70% of 50)           40 (80% of 50)
Cohort 3 (50 submissions)..........................................  .......................  .......................           25 (50% of 50)           30 (60% of 50)           35 (70% of 50)
Cohort 4 (50 submissions)..........................................  .......................  .......................  .......................           25 (50% of 50)           30 (60% of 50)
Cohort 5 (50 submissions)..........................................  .......................  .......................  .......................  .......................           25 (50% of 50)
                                                                    ----------------------------------------------------------------------------------------------------------------------------
    Total Target for 45 Day Review Metric..........................                       75                      115                      160                      210                      265
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                        Example 3: Resubmissions

       If participants submit 75 resubmissions in fiscal year 
     2008; 99 resubmissions in fiscal year 2009; 123 resubmissions 
     in fiscal year 2010; 147 resubmissions in fiscal year 2011; 
     and 171 resubmissions in fiscal year 2012, the review metrics 
     will be as follows:

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                                                                                                                              FY 10: 123               FY 11: 147               FY 12: 171
                                                                     FY 08: 75 resubmissions  FY 09: 99 resubmissions       resubmissions            resubmissions            resubmissions
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Cohort 1 (75 submissions)..........................................           37 (50% of 75)           45 (60% of 75)           52 (70% of 75)           60 (80% of 75)           68 (90% of 75)
Cohort 2 (24 submissions)..........................................  .......................           12 (50% of 24)           14 (60% of 24)           17 (70% of 24)           19 (80% of 24)
Cohort 3 (24 submissions)..........................................  .......................  .......................           12 (50% of 24)           14 (60% of 24)           17 (70% of 24)
Cohort 4 (24 submissions)..........................................  .......................  .......................  .......................           12 (50% of 24)           14 (60% of 24)
Cohort 5 (24 submissions)..........................................  .......................  .......................  .......................  .......................           12 (50% of 24)
                                                                    ----------------------------------------------------------------------------------------------------------------------------
    Total Target for 30 Day Review Metric..........................                       37                       57                       78                      103                      130
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