CSMS Message: 14-000489

TO: ALL FILERS

FROM: FOOD & DRUG ADMINISTRATION

SUBJECT: FDA contingency on September 06, 2014 for PNSI (Stand-alone Prior Notice filing via FDA website will not be available)

FDA's PNSI system will be down for maintenance starting at 1:00 am September 06, 2014 and is not anticipated to be back up until 10:00 am September 06, 2014. As a result, FDA will be operating under prior notice contingency scenario 4 during this time. During this downtime, ACS, OASIS and the link between ACS and OASIS will be operational. In this situation, prior notice may continue to be submitted through ABI/ACS. However, PNSI will not be available as noted.

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 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, FDA will provide a link to a form on their website that will allow for prior notice to 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 the PNSI downtime (21 CFR 1.280 (c)).

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 FDA's prior notice center at (866) 521-2297.