CSMS Message: 13-000338

To: All Filers

From: Food & Drug Administration

Subject: Scheduled PNSI Downtime on July 13, 2013

Due to scheduled maintenance, FDA's PNSI system will be down at approximately 1:00 am, and is not anticipated to be back up until 8:00 am. As a result, FDA will be operating under the prior notice contingency scenario 4 during this time. During this downtime ACS, OASIS and the link between ACS and OASIS are operational. However, PNSI will be unavailable. In this situation, prior notice may continue to be submitted through ABI.

If prior notice has been submitted via PNSI prior to the system outage and a confirmation number has already been received, the confirmation number must accompany the article of food (21 CFR 1.279 (g)). In addition, FDA and CBP recommend that the submitter also provide the PNSI Web Entry Summary Confirmation page, including the prior notice confirmation number and time stamp, to CBP officers for cargo release.

Otherwise, if prior notice has not been submitted prior to the system outage, it may be submitted by either e-mail or fax (21 CFR 1.280(c)). FDA does not intend to accept any prior notice submitted by these methods other than during PNSI/OASIS downtime (21 CFR 1.280 (e)).

Filers may decide to wait out the PNSI downtime if they determine that the timeliness of prior notice will not be adversely affected. Filers who choose this option should understand that they remain responsible under section 801(m) of the act and under the prior notice final rule for filing timely prior notice.

If prior notice has already been submitted via ABI/ACS or PNSI prior to the outage, and confirmation has already been received, the submitter may proceed with prior notice using the standard process. If you have any questions during this downtime, please contact the FDA's Division of Food Defense Targeting (Prior Notice Center) at (866) 521-2297.