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  1. Generic Drug User Fee Amendments

Q1. Who will be required to pay a backlog fee?

Each person that owns an original ANDA that is pending on October 1, 2012 and that has not been tentatively approved on that date will be required to pay a backlog fee for that ANDA.

Q2. How will FDA define pending applications for purposes of paying the backlog fee?

Any original ANDA that has not been withdrawn, tentatively approved, or approved by September 28, 2012, is considered pending and is subject to a backlog fee.   

Q3. How much is the backlog fee and when will it be due?

The backlog fee is $17,434.  It is due on or before November 26, 2012.

On October 25, 2012, a notice was published in the Federal Register regarding generic drug user fee rates for backlog applications.  The notice was required by the GDUFA statute (PL 112-144), see FDCA §744B(a)(1)(C).  That statute sets the due date for backlog fees at "30 calendar days after the date of the publication of the notice" in the Federal Register, see §744B(a)(1)(D).  Thirty calendar days after October 25, 2012 is November 24, 2012, which is a Saturday.  Given that this is not a business day for the U.S. Government, the fee due date will be the next business day.  Fees received on or before Monday, November 26, 2012 will be deemed to have been submitted on or before the due date. 

Additional information, including the methodology for calculating the fee, is available in Generic Drug User Fee - Backlog Fee Rate for Fiscal Year 2013.

Q4. If an original ANDA has been submitted to FDA before October 1, 2012, but has not been accepted for review, will this ANDA be subject to a backlog fee?


Q5. If FDA refuses to receive an application in the backlog, will the backlog fee be refunded?


Q6. What is the penalty for failure to pay the backlog fee?

Any person that owns an original ANDA that fails to pay the backlog fee will be placed on a publicly available arrears list, and FDA will not receive a new ANDA or supplement submitted by that person, or any affiliate (see next question and answer) of that person, within the meaning of 505(j)(5)(A) of the Federal Food, Drug and Cosmetic Act, until the outstanding fee is paid.

Note: The fee is an obligation to the U.S. government, and the failure to pay the fee may result in collection activities by the government pursuant to applicable laws.

Q7. What is an affiliate for this purpose?

GDUFA defines the term affiliate as a business entity that has a relationship with a second business entity if, directly or indirectly, one business entity controls, or has the power to control, the other business entity; or a third party controls, or has power to control, both of the business entities.

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