Regulations and Federal Register Documents (PDUFA)

Regulations

• Complete Response Letter Final Rule

Federal Register Documents  

• Establishment of Prescription Drug User Fee Rates for Fiscal Years 1998 - present  
  List of Federal Register notices that announce the drug user fee rates for each fiscal year    
   

• An Evaluation of the Prescription Drug User Fee Act Workload Adjuster, Request for Comments (PDF - 179KB) (posted 5/7/2013)

• PDUFA Patient-Focused Drug Development: Announcement of Disease Areas for Meetings Conducted in Fiscal Years 2013-2015 (PDF - 200KB) (posted 4/11/2013)  

• Notice: Cooperative Agreement to Support Regulatory Research Related to Food and Drug Administration Commitments under the 2012 Prescription Drug User Fee Act (PDF - 205KB) (posted 3/19/2013)

  • Cooperative Agreement to Support Regulatory Research Related to Food and Drug Administration Commitments under the 2012 Prescription Drug User Fee Act (PDF - 156KB)
    

• Prescription Drug User Fee Act V Benefit-Risk Plan; Request for Comments (PDF - 220KB) (posted 3/8/2013)

• Privacy Act of 1974; Report of a New System of Records; Food and Drug Administration User Fee System (PDF - 206KB) (posted 11/14/2012)
  

• Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug User Fee Cover Sheet; Form FDA 3397 (PDF - 223KB) (posted 10/22/2012)

• PDUFA Patient-Focused Drug Development: Public Meeting and Request for Comments (PDF - 203KB) (posted 9/24/2012)
  

• PDUFA Patient-Focused Drug Development: Consultation Meetings; Request for Notification of Patient Stakeholder Intention to Participate (PDF - 187KB) (posted 9/24/2012)

• Fee for Using a Priority Review Voucher in Fiscal Year 2013 (PDF - 191KB) (posted 9/13/2012)

• Assessment of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act V; Request for Comments (PDF - 177KB) (posted 7/6/2012)

  • Statement of Work for Assessment of Program (PDF - 193KB)

• Agency Information Collection Activities: Proposed Collection; Comment Request; User Fee Cover Sheet; Form 3397 (PDF - 176KB) (posted 5/21/2012)

• Notice of Availability: Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (PDF - 144KB) (posted 9/27/2011)

  • Guidance (PDF - 287KB)

• Notice of Availability: Prescription Drug User Fee Act IV Information Technology Plan (PDF - 152KB) (posted 9/19/2011)

  • PDUFA IV Information Technology Plan (PDF - 492KB)

• Prescription Drug User Fee Act; Notice of Public Meeting, October 24, 2011 (PDF - 160KB) (posted 9/19/2011)

• Fee for Using a Priority Review Voucher in Fiscal Year 2012 (PDF - 153KB) (posted 8/31/2011)

• Notice of Comment Request: Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (PDF -181KB) (posted 7/13/2011)

• Notice of Availability: Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (PDF - 189KB) (posted 3/11/2011)

• Prescription Drug User Fee Act; Reopening of the Comment Period (PDF - 49KB) (posted 11/10/2010)

• Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request for Comments; November 2-3, 2010 (PDF - 109KB) (posted 10/6/2010)

  • More Information about the Public Hearing

• Fee for Using a Priority Review Voucher in Fiscal Year 2011 (PDF - 51KB) (posted 9/13/2010)

• Prescription Drug User Fee Act; Meetings on Reauthorization; Request for Notification of Stakeholder Intention to Participate (PDF - 51KB) (issued 6/8/2010)

• Prescription Drug User Fee Act; Notice of Public Meeting, April 12, 2010 (PDF - 52KB) (issued 3/16/2010)

• Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; User Fee Cover Sheet; Form FDA 3397 (PDF - 48KB) (posted 11/19/2009)

• Correction to Prescription Drug User Fee Rates for Fiscal Year 2010 (PDF - 58KB) (posted 11/13/2009)

• Pilot Program To Evaluate Proposed Proprietary Name Submissions; Procedures To Register for Participation and Submit Data or (PDF - 56KB) (posted 10/1/09)

• Notice of Availability: PDUFA IV IT Assessment (PDF -  50KB) (issued 8/21/2009) 

  • PDUFA IV IT Assessment (PDF - 306KB)

• Public Comment on Proprietary Name Review or (PDF - 49KB) (posted 12/23/08)

• Contents of a Complete Submission for the Evaluation of Proprietary Names draft guidance or (PDF - 47KB) (Posted 11/24/08)

  • Draft Guidance (PDF - 255KB)

• PDUFA Pilot Project Proprietary Name Review Concept Paper or (PDF - 53KB) (posted 10/7/08)

• Concept Paper (PDF - 295KB)

• Notice of Availability: PDUFA Information Technology Plan (issued 6/30/2008)

  • PDUFA IV Information Technology Plan (PDF - 696KB)

• Notice of Availability: Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan or (PDF - 47KB) (posted May 5, 2008)

  • Draft Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan (PDF - 114KB) (4/1/2008)

• Notice of Availability: Draft Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan (PDF - 52KB) (Posted 1/4/2008)

  • Draft PDUFA IV Information Technology Plan (PDF - 2170KB)

• Prescription Drug User Fee Act; Public Meeting, February 16, 2007 or (PDF - 95KB) (posted 1/11/2007)

  • FDA News Release
  • Fact Sheet
  • Meeting agenda
  • Meeting presentations

• Prescription Drug User Fee Act; Public Meeting or (PDF - 62KB) (10/18/2005)
  On November 14, 2005, FDA held a public meeting on PDUFA and at the same time opened a public docket (2005N-0410) where people can submit written comments.

  •  More information on the public meeting
  •  FDA News Release 

• Notice of Availability: Guidance for Industry and Food and Drug Administration Staff: Application User Fees for Combination Products or (PDF - 50KB).  The Final Guidance (5/3/2005) 

• Notice of Availability: Draft Guidance for Industry on User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR or (PDF - 50KB).  The Draft Guidance (PDF - 46KB) (posted 4/19/2005) 

• Notice of Availability: Guidance for Industry on Good Review Management Principles for PDUFA Product or (PDF - 52KB).  The Final Guidance (PDF - 683KB) (posted 4/11/2005) 

• Notice to Industry on the Development of a Web-Based System for Obtaining a User Fee Payment Identification Number and Prescription Drug User Fee Cover Sheet (FDA Form 3397); Availability or (PDF - 47KB) (3/10/2005) 

• Notice of Availability: Guidance for Industry on Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees or (PDF - 50KB).  The Final Guidance (PDF - 212KB) (1/3/2005) 

• Notice of Availability: Draft Guidance for Industry and Food and Drug Administration Staff: Application User Fees for Combination Products or (PDF - 53KB).  The Draft Guidance (PDF - 1MB) (9/29/2004) 

•  Statement of Work for the Evaluation of First Cycle Review Performance, Availability or (PDF - 37KB) (posted 10/21/2003) 

  • Sample Statement of Work for the Evaluation of First Cycle Review Performance (PDF - 88KB) (10/21/2003)

• Prescription Drug User Fee Act (PDUFA); Public Meeting; Correction or (PDF - 33KB) (12/4/2001)

• Prescription Drug User Fee Act (PDUFA); Public Meeting Notice or (PDF - 47KB) (11/21/2001)

• Delegations of Authority and Organization; Office of the Commissioner and the Center for Drug Evaluation and Research (64 FR 59617, November 3, 1999) (PDF - 146KB) (11/19/1999) 

  Note: This notice transfers the waiver program to CDER. It also has the address where waiver requests can be submitted.