| Title: | Prior Notice Problem with WP Application |
|---|---|
| Date: | 2010-03-23 |
| To: | abi |
| Links: | previous, next |
Currently, the ABI application that is used to file the stand-alone Bio-Terrorism (prior notice) information (the WP application) is encountering a problem with the entry-type affirmation of compliance. That affirmation code is ETP. The system is sometimes, but not always, rejecting for the ETP being missing – even if it was transmitted.
Until this problem is fixed, there are some procedures that can be used to obtain the prior notice confirmation (PNC) numbers. The filer can use the FDA website (PNSI) to get the PNC number. In addition, the filers can transmit the entry/entry summary using the EI, HI and HN transmissions to add the prior notice data.
The trade will be notified when the problem has been corrected.
CSMS #10-000087