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U.S. Department of Health and Human Services

For Industry

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GDUFA Cover Sheet Clarifications: Backlog

FDA is issuing clarifying information for applicants that are required to pay the one-time backlog fee for ANDAs that were in a pending status as of October 1, 2012.

1. Completing the Cover Sheet for Backlog Fee 

A validation process occurs within the User Fee System (see Figure 1) to match the ANDA Number to the Applicant Name that was listed in FDA’s records as of October 1, 2012. Please be advised that the Applicant Name for this validation process may not be the most current name per your records. If you have previously submitted a request for a name change or a transfer of ownership, the older name may be displayed in the User Fee System.  If you recognize the Applicant Name as a company that was previously designated as the applicant, then you can proceed to complete the cover sheet with this discrepancy. Upon receipt of your cover sheet and payment submission, FDA will review these discrepancies and follow up with applicants as needed.

Figure 1: User Fee System Screen Shot for Backlog Fee
Figure 1: User Fee System Screen Shot for Backlog Fee

 2. Submission of Signed Cover Sheet for Backlog Fee

After completing the online cover sheet process and paying the backlog fee, applicants are advised to submit a signed copy (original or scanned) of the cover sheet along with Form FDA 356h. The 356h only needs to be completed with minimal information in order for FDA to receive and process the submission.

The following fields are required to be completed on the 356h:

  • Fields 1, 2, 7, and 9
  • For field 21, select "Other" and state "GDUFA Cover Sheet."
  • For field 22, leave blank.
  • For field 31, check #18 for User Fee Cover Sheet.
  • Fields 32 -38