Regulatory Open Forum

 View Only

  • 1.  Cost for FOIA request for electronic format

    Posted 07-Feb-2019 09:06
    Does anyone have experience with requesting documents from FDA and receiving the document in electronic format?

    I presume that the days of electronic copies are now the preferred method of delivery, so page charges are irrelevant. The only information on the website is "actual cost for form / format requested." Is there a way to estimate that?


    https://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm

    ------------------------------
    Jean Bigoney PhD, RAC, CQE
    Regulatory Affairs Specialist
    Morrisville
    United States
    ------------------------------


  • 2.  RE: Cost for FOIA request for electronic format

    Posted 07-Feb-2019 14:03
    Hi Jean,

    I have put in a ballpark estimate and then someone from the department will contact you and tell you how much. I normally put in $100 sometimes its more sometimes less.

    ------------------------------
    Caitlin Abell RAC
    Senior Manager Global Regulatory Affairs
    East Walpole MA
    United States
    ------------------------------

    Original Message


  • 3.  RE: Cost for FOIA request for electronic format

    Posted 08-Feb-2019 04:50
    Edited by Richard Vincins 08-Feb-2019 04:49
    I can comment that it is around $100 - my last FOI request for a 510(k) submission did cost $115.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 4.  RE: Cost for FOIA request for electronic format

    Posted 08-Feb-2019 13:31
    ​Hi Jean,
    I have requested copies of 510(k)s in the past through the FOIA, and the cost is a little less than a dollar per page. So for a ~300 page redacted 510(k), I have paid around 250$. I've also received some shorter documents, at a cost of maybe 50-75$. There is a cost regardless of whether it is emailed or mailed to you. You might be able to qualify for a fee reduction for a small, noncommercial requests. Also keep in mind that the wait times can vary. For example, if your request goes through CDRH, you can expect a 1-3 year wait. They will contact you with an exact price when they get to your FOIA request.
    I hope this helps.
    Catherine

    ------------------------------
    Catherine Campbell RAC
    Associate Director, Regulatory Affairs CMC
    Novato CA
    United States
    ------------------------------

    Original Message


  • 5.  RE: Cost for FOIA request for electronic format

    Posted 08-Feb-2019 08:30
    We have requested only electronic documents for the past several years.  The cost is based on the time to retrieve the requested documents plus the time to create the CD/DVD.  No cost to copy, like there used to be.   If the document has been requested before, the cost is lower, as it is probably already in electronic form.  My understanding is that many documents are now only in electronic form, so retrieval is simpler.  It is the "older" documents that may not be electronic that take more time (more $$) to retrieve.  


    ------------------------------
    Melissa Walker RAC
    President & CTO
    St Louis MO
    United States
    ------------------------------

    Original Message


Related Content