Manual of Standard Operating Procedures and Policies

Regulatory - License Applications
Procedures for the Classification of Resubmissions of an Application for a Product Covered by the Prescription Drug User Fee Act (PDUFA III)
SOPP 8405.1	Version #2	August 30, 2002

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1. Purpose

This document provides instruction to CBER staff on the policies and procedures for the classification of resubmissions of license applications and efficacy supplements for products covered by PDUFA III.

2. Definitions

Resubmission

An applicant's complete response to an action letter.

Class 1 Resubmission

A Class 1 resubmission is a complete response to an action letter for an application that is determined by the FDA to include only the following items or a combination of these items:

1. Final printed labeling;
2. Draft labeling;
3. Safety updates submitted in the same format, including tabulations, as the original safety submissions 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 analysis of data previously submitted to the application (determined by the Agency as fitting the Class 1 category);
9. Other minor clarifying information (determined by the Agency as fitting the Class 1 category), and
10. Other specific items that may be added later as the Agency gains experience with the scheme.

Class 2 Resubmission

A Class 2 resubmission is a resubmission of an application that includes any other items, as well as any item that would warrant presentation to an advisory committee or re-inspection of facilities.

3. Background

In 1992, as an addendum to PDUFA, the Agency committed to responding to the applicant's resubmission to an FDA action letter in 6 months. In its letter to Congress setting out the performance goals regarding the Food and Drug Administration Modernization Act of 1997 (FDAMA), in which PDUFA was reauthorized, the Agency committed to goals for two classes of resubmissions of applications: Class 1 and Class 2 resubmissions. With the reauthorization of PDUFA (PDUFA III), these performance goals were extended to the resubmission of efficacy supplements. The classifications of the resubmissions will be based on the information contained in the resubmission.

The performance goals for resubmissions of New Drug Applications and License Applications are as follows:

Original Applications

• Class 1

  • Standard - 90% in 2 months
  • Priority - 90% in 2 months

• Class 2

  • Standard - 90% in 6 months
  • Priority - 90% in 6 months

Efficacy Supplements

• Class 1

  • FY 03- 90% in 6 months, 30% in 2 months
  • FY 04- 90% in 4 months, 50% in 2 months
  • FY 05- 90% in 4 months, 70% in 2 months
  • FY 06- 90% in 4 months, 80% in 2 months
  • FY 07- 90% in 2 months

• Class 2

  • FY 03- 90% in 6 months
  • FY 04- 90% in 6 months
  • FY 05- 90% in 6 months
  • FY 06- 90% in 6 months
  • FY 07- 90% in 6 months

4. Policy

• The content of an amendment submitted by an applicant near or at the time an action letter issues, may be considered in determining the completeness of the response to the action letter and the classification of the resubmission.
• A letter (Appendix 1) will be issued to the applicant acknowledging the resubmission, stating the classification of the response, and giving the goal date for the review.
• Although the performance goals provide for a gradual yearly decrease in time for review, as resources permit it is FDA's intent to complete the review and act on Class 1 resubmissions of efficacy supplements within 2 months of receipt.

5. Responsibilities and Procedures

Review Committee

• Determines whether the submission is a complete response to the action letter and qualifies as a resubmission,

• Uses the numbered items in the definition of Class 1 resubmission to determine the classification of the resubmission.,

  • forwards Class 1 decisions, based on item 8 or 9 in the above list, to the Review Management Coordinating Committee (RMCC) for confirmation, through the Regulatory Project Manager, and

• Completes the review and acts on resubmissions of applications within the time frames set out in the Background of this SOPP.

Regulatory Project Manager

The Regulatory Project Manager ensures that

• the appropriate entries are made into the data management system,

• the applicant is notified when a submission is determined to be incomplete (and therefore not a resubmission) and ensures that the clock has not started and will not start until a complete response to the action letter is received,

• questions of classification based on items 8 or 9 in the definition of Class 1 are brought to the RMCC in a timely manner,

• an acknowledgement letter stating the classification of the resubmission and the goal date is targeted to issue to the applicant within 2 weeks but no later than 3 weeks. More time may be necessary for RMCC deliberations.

RMCC

• Reviews and confirms or overturns the review committee's decision that a resubmission is Class 1 based on items 8 or 9 in the definition.
6. Effective Date

October 1, 2002

7. Appendix

   Appendix 1: Resubmission Acknowledgement Letter (PDF - 14 KB)

8. References

Letter from Secretary, Department of Health and Human Services, transmitting the PDUFA III Performance Goals and Procedures, June 4, 2002.

9. History

Comment/Revision	Approved By	Approval Date	Version Number	Comment
Rebecca Devine, PhD	Rebecca Devine, PhD	5/20/1998	1	Original
Leonard Wilson	Robert Yetter, PhD	8/30/2002	2	PDUFA III Changes

 

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