The FDA is looking for industry comments for its draft guidance, Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1). The guidance serves as a Frequently Asked Questions (FAQ) guide for the Generic Drug User Fee Amendments (GDUFA), using a Q&A format to promote transparency and facilitate compliance.
The first version of the guidance was posted on FDA's website on August 22, 2012. The revision is intended to clarify some questions and answers from the previous version, and will add new ones that have arisen since the launch of the program. To comment on the new guidance, visit 1.usa.gov/17WgGuC. The original Q&A guidance is a PDF that can be downloaded at 1.usa.gov/1fZCtnW.
According to an agency statement, "This guidance is intended to provide updated answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding the requirements and commitments of GDUFA."
Here's a sample question from the first draft guidance:
Q38. How can a facility be sure that it is no longer identified in an ANDA so that it no longer incurs new user fees?
An ANDA sponsor should remove from the ANDA any reference to a facility as a manufacturing facility when that facility no longer manufactures its API or FDF, and when it no longer seeks to retain the facility as an approved manufacturer of the API or FDF.
An ANDA sponsor can identify a facility that it does not own in its application only if the owner of that facility has provided the ANDA sponsor permission to refer to the facility. If the owner of the facility withdraws that permission, FDA will consider that facility to no longer be identified in the application as of the date when FDA receives notice of that withdrawal. Note, however, that if the permission is withdrawn the facility will no longer be approved for manufacture of the FDF, or the API, covered by that application. Since a facility continues to incur facility fee(s) until FDA is notified of the facility’s withdrawal of permission, the Agency encourages a person who wishes to withdraw permission for its facility to be identified in an ANDA to take the following steps:
- 1. Notify the ANDA sponsor and/or DMF holder in writing that it is withdrawing its permission to reference the facility in its ANDA and/or DMF.
- 2. Send copies of this letter to the Office of User Fee Collections and Budget Formulation at CDERCollections@fda.hhs.gov in addition to standard application submission methods for ANDAs and DMFs (via FDA electronic gateway or by mail to the ANDA archival file at the following address: Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Document Control Room, Metro Park North VII, 7620 Standish Pl., Rockville, MD 20855).
- 3. If you are a DMF holder, be sure to also update your DMF with this change.
Comments on the guidance are welcome at any time, but the FDA stressed that comments should be received by Nov. 12, 2013 so that there will be time to consider them before it begins work on the final version of the guidance. For more information on submitting your GDUFA questions, visit the guidance's Federal Register page.