Applications Submitted During Shutdown Period and Acceptance Dates

FDA notes on its User Fee web page (here) that the key date for acceptance of NDAs, BLAs, and ANDAs will be dictated by the first date that FDA could accept fees under the appropriation (after the shut down was over) which is January 28, 2019.  The Agency gives the following advice as to how it will treat fee-paying applications and time periods for which fees must be paid (if not submitted at time of original submission of the application) (please see below):

  • For ANDAs transmitted to FDA during the lapse period, the sponsor will have a 20-day window, until February 18, 2019, to pay the fee. If the fee is satisfied within that 20-day period, and if the ANDA is found otherwise to meet the criteria for receipt, the receipt date will be the first business day on which the FDA reopened, i.e., January 28, 2019. If the fee is not satisfied within that 20-day period and the ANDA is found to otherwise meet the criteria for receipt, the receipt date for the submission will be set to the date on which that liability is satisfied. This 20-day grace period is provided by statute.
  • For NDAs and BLAs transmitted to FDA during the lapse period, the sponsor will have a 5-day window, until February 1, 2019, to pay the fee. If the fee is satisfied within that 5-day period, the receipt date will be the first business day after the FDA reopened, January 28, 2019. If the fee is not satisfied within that 5-day period, the receipt date for the submission will be set to the date on which that liability is satisfied. This 5-day grace period is not provided by statute but reflects FDA’s normal practice.

So now we have the answer!

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