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  • 1.  facility fees for FY2014

    Posted 19-Mar-2013 09:35
    Hello,
    I have a question regarding the facility fees for FY2014.  The FDA Q&A website says:

    In FY 2013, fees will be due by March 4, 2013.
    Fees for FYs 2014-2017 will be due on the first business day on or after October 1 of each fiscal year, or the first business day after the enactment of an appropriations Act that provides for the collection and obligation of fees.

    however,

    The Federal government's fiscal year begins on October 1 and ends on September 30.  For example, fiscal year 2002 begins October 1, 2001, and ends September 30, 2002. Fiscal year 2003 begins October 1, 2002 and ends September 30, 2003.

     

    Given the information provided in the 2 responses above, does this mean that the fee/payment for fiscal year 2014 is due on October 1, 2013?


    Thank you in advance for your response.

    -------------------------------------------
    Audrey Egan
    Ethypharm USA Corp.
    Philadelphia PA
    United States
    -------------------------------------------


  • 2.  RE:facility fees for FY2014

    Posted 20-Mar-2013 07:41
    Audrey,

    You're 100% correct with your understanding. This Calendar year the generic industry will be assessed two establishment fees for FY2013 and FY2014. I work for a small generic company and we only have one facility subject to a fee. Just think how much a Mylan or Waston pays for their facility fees? I think GPHA did a horrible job working with FDA on GDUFA. If a company has a NDA and an ANDA you get two establishment fees for the same facility one under PDUFA  for $520,100 and one under GDUFA for $170,000.  

    Regards,

    John
    -------------------------------------------
    John Lay
    Director, Regulatory and Quality
    Vistapharm Inc.
    Largo FL
    United States
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    Original Message


  • 3.  RE:facility fees for FY2014

    Posted 20-Mar-2013 08:07
    Hi Audrey.

    Short answer is technically "yes" fees for 2014 will be due on Oct 1, 2013.  However, if the budget is not passed and signed before that date, then the fees will become due on the first business day after the budget authorizing their collection is finalized.
    -------------------------------------------
    Victor Mencarelli
    Regulatory Affairs Specialist
    United States
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    Original Message