PRIOR NOTICE CONTINGENCY PLAN

1. Scenario 1: ACE, OASIS, and PNSI are working, but the link between ACE and OASIS is down.

The outage described in this scenario would prevent submitters who filed via ABI/ACE from receiving prior notice confirmation and would prevent CBP from auto-checking the prior notice confirmation for ABI/ACE and PNSI filers.

If deemed appropriate, FDA will post a notice at https://www.access.fda.gov (see log-in page) and will request that CBP post a message through the Cargo Systems Messaging Service (CSMS) website advising of any available downtime specifics.

If prior notice has not been submitted, ABI filers may decide to wait out the ACE/OASIS interface downtime if the timeliness of prior notice will not be affected. Filers who choose this option remain responsible for filing timely prior notice under section 801(m) of the Act and under the prior notice final rule.

Alternatively, filers may submit prior notice via PNSI, in which case the prior notice confirmation number must accompany the article of food and must be provided to CBP or FDA upon arrival (21 CFR 1.279(g)). In addition, FDA and CBP recommend that the PNSI confirmation page, including the prior notice confirmation number and time stamp, be provided to CBP officers for cargo release. If the PNSI confirmation page is not provided, it may delay cargo release.

If prior notice was submitted via ABI/ACE and a prior notice confirmation number has been received before the interface outage, the submitter may proceed with prior notice using the standard process. However, if prior notice was submitted via ABI/ACE but a prior notice confirmation number has not been received before the interface outage, submitters should provide a signed copy of the ABI transmission or other evidence to show that prior notice has been submitted via ABI/ACE, to CBP officers at the time of cargo release.

FDA intends to post a notice once normal processing has resumed at https://www.access.fda.gov (see log-in page) and will request that CBP post a similar message on the CSMS website.

The outage described in this scenario would prevent submitters who filed via ABI/ACE from receiving prior notice confirmation and would prevent CBP from auto-checking the prior notice confirmation for ABI/ACE and PNSI filers.

If deemed appropriate, FDA will post a notice at https://www.access.fda.gov (see log-in page) and will request that CBP post a message through the Cargo Systems Messaging Service (CSMS) website advising of any available downtime specifics.

If prior notice has not been submitted, ABI filers may decide to wait out the OASIS downtime if the timeliness of prior notice will not be affected. Filers who choose this option remain responsible for filing timely prior notice under section 801(m) of the Act and under the prior notice final rule.

Alternatively, filers may submit prior notice via PNSI, in which case the prior notice confirmation number must accompany the article of food and must be provided to CBP or FDA upon arrival (21 CFR 1.279(g)). In addition, FDA and CBP recommend that the PNSI confirmation page, including the prior notice confirmation number and time stamp, be provided to CBP officers for cargo release. If the PNSI confirmation page is not provided, it may delay cargo release.

If prior notice was submitted via ABI/ACE and a prior notice confirmation number has been received before the interface outage, the submitter may proceed with prior notice using the standard process. However, if prior notice was submitted via ABI/ACE but a prior notice confirmation number has not been received before the interface outage, submitters should provide a signed copy of the ABI transmission or other evidence to show that prior notice has been submitted via ABI/ACE, to CBP officers at the time of cargo release.

FDA intends to post a notice once normal processing has resumed at https://www.access.fda.gov (see log-in page) and will request that CBP post a similar message on the CSMS website.

The outage described in this scenario would prevent submitters from filing prior notice via PNSI, prevent submitters who filed via ABI/ACE from receiving prior notice confirmation, and prevent CBP from auto-checking the prior notice confirmation for ABI/ACE and PNSI filers.

If deemed appropriate, FDA will post a notice at https://www.access.fda.gov (see log-in page) and will request that CBP post a message through the Cargo Systems Messaging Service (CSMS) website advising of any available downtime specifics.

If prior notice has not been submitted, filers may decide to wait out the OASIS and PNSI downtime if the timeliness of prior notice will not be affected. Filers who choose this option remain responsible for filing timely prior notice under section 801(m) of the Act and under the prior notice final rule.

If prior notice was submitted via ABI/ACE and a prior notice confirmation number has been received before the system outage, the submitter may proceed with prior notice using the standard process. However, if prior notice was submitted via ABI/ACE but a prior notice confirmation number has not been received before the outage, submitters should provide a signed copy of the ABI transmission showing the prior notice submission, or other evidence to show that prior notice has been submitted via ABI/ACE, to CBP officers at the time of cargo release.

If prior notice was submitted via PNSI, the confirmation number must accompany the article of food and must be provided to CBP or FDA upon arrival (21 CFR 1.279(g)). In addition, FDA and CBP recommend that the PNSI confirmation page, including the prior notice confirmation number and time stamp, be provided to CBP officers for cargo release.

If the PNSI confirmation page is not provided, this may delay cargo release. If prior notice was not submitted via PNSI or ABI/ACE, prior notice must be submitted by either e-mail or fax. FDA will not accept prior notice submitted by these methods other than during a PNSI downtime

1. E-mail Submission

FDA will provide a link to the contingency submission form (FDA 3540) at https://www.access.fda.gov (see log-in page) and will request that CBP post a message on the CSMS website. When this option is activated, the FDA’s Division of Food Defense Targeting (DFDT) intends to send an automated receipt response, including the prior notice confirmation number, to the e-mail address from which the prior notice was submitted. A paper copy of the e-mail receipt confirmation should be presented to the CBP officer for cargo release. CBP intends to enforce prior notice submission time frames based on the email receipt confirmation time stamp.

1. Fax Submission

FDA will publish the fax number to the DFDT at https://www.access.fda.gov (see log-in page) and will request that CBP post a message on the CSMS website. When this option is activated, DFDT intends to return a fax acknowledgement report, including the prior notice confirmation number. The fax acknowledgement report should be presented to the CBP officer for cargo release. CBP intends to enforce prior notice submission time frames based on the fax acknowledgement report confirmation time stamp.

FDA intends to post a notice once normal processing has resumed at https://www.access.fda.gov (see log-in page) and will request that CBP post a similar message on the CSMS website.

The outage described in this scenario would prevent submitters from filing prior notice via PNSI and prevent CBP from auto-checking the prior notice confirmation for PNSI filers.

If deemed appropriate, FDA will post a notice at https://www.access.fda.gov (see log-in page) and will request that CBP post a message through the Cargo Systems Messaging Service (CSMS) website advising of any available downtime specifics.

In this situation, prior notice may be submitted through ABI/ACE. If prior notice has not been submitted, PNSI filers may decide to wait out the PNSI downtime if the timeliness of prior notice will not be affected. Filers who choose this option remain responsible for filing timely prior notice under section 801(m) of the Act and under the prior notice final rule.

If prior notice was submitted via PNSI and a confirmation number has been received before the system outage, the confirmation number must accompany the article of food and must be provided to CBP or FDA upon arrival (21 CFR 1.279(g)). In addition, FDA and CBP recommend that the PNSI confirmation page, including the prior notice confirmation number and time stamp, be provided to CBP officers for cargo release. If the prior notice confirmation page is not provided, it may delay cargo release.

If prior notice was not submitted before the system outage, it may be submitted by either e-mail or fax. FDA will not accept prior notice submitted by these methods other than during PNSI downtime.

1. E-mail Submission

FDA will provide a link to the contingency submission form (FDA 3540) at https://www.access.fda.gov (see log-in page) and will request that CBP post a message on the CSMS website. When this option is activated, the FDA’s Division of Food Defense Targeting (DFDT) intends to send an automated receipt response, including the prior notice confirmation number, to the e-mail address from which the prior notice was submitted. A paper copy of the e-mail receipt confirmation should be presented to the CBP officer for cargo release. CBP intends to enforce prior notice submission time frames based on the email receipt confirmation time stamp.

2. Fax Submission

FDA will publish the fax number to the DFDT at https://www.access.fda.gov (see log-in page) and will request that CBP post a message on the CSMS website. When this option is activated, DFDT intends to return a fax acknowledgement report, including the prior notice confirmation number. This fax acknowledgement report should be presented to the CBP officer for cargo release. CBP intends to enforce prior notice submission time frames based on the fax acknowledgement report confirmation time stamp.

FDA intends to post a notice once normal processing has resumed at https://www.access.fda.gov (see log-in page) and will request that CBP post a similar message on the CSMS website.

The outage described in this scenario would prevent submitters who filed via ABI/ACE from receiving prior notice confirmation and prevent CBP from auto-checking the prior notice confirmation for ABI/ACE and PNSI filers.

If deemed appropriate, FDA will post a notice at https://www.access.fda.gov (see log-in page) and will request that CBP post a message through the Cargo Systems Messaging Service (CSMS) website advising of any available downtime specifics.

If prior notice has not been submitted, ABI filers may decide to wait out the ACE downtime if the timeliness of prior notice will not be affected. Filers who choose this option remain responsible for filing timely prior notice under section 801(m) of the Act and under the prior notice final rule.

If prior notice was submitted via ABI/ACE and a prior notice confirmation number has been received before the system outage, the submitter may proceed with prior notice using the standard process. However, if prior notice was submitted via ABI/ACE but a prior notice confirmation number has not been not received before the outage, submitters should provide a signed copy of the ABI transmission, or other evidence to show that prior notice has been submitted via ABI/ACE, to CBP officers at the time of cargo release.

Filers that need to submit prior notice while ACE is down must submit through PNSI (21 CFR 1.280(b)). If prior notice has been submitted via PNSI, the confirmation number must accompany the article of food and must be provided to CBP or FDA upon arrival (21 CFR 1.279(g)). In addition, FDA and CBP recommend that the PNSI confirmation page, including the prior notice confirmation number and time stamp, be provided to CBP officers for cargo release. If the PNSI confirmation page is not provided, it may delay cargo release.

FDA intends to post a notice once normal processing has resumed at https://www.access.fda.gov (see log-in page) and will request that CBP post a similar message on the CSMS website.

The outage described in this scenario would prevent submitters from filing prior notice via PNSI, prevent submitters who filed via ABI/ACE from receiving prior notice confirmation, and prevent CBP from auto-checking the prior notice confirmation for ABI/ACE and PNSI filers.

If deemed appropriate, FDA will post a notice at https://www.access.fda.gov (see log-in page) and will request that CBP post a message through the Cargo Systems Messaging Service (CSMS) website advising of any available downtime specifics.

If prior notice has not been submitted, filers may decide to wait out the downtime if the timeliness of prior notice will not be affected. Filers who choose this option remain responsible for filing timely prior notice under section 801(m) of the Act and under the prior notice final rule.

If prior notice was submitted via ABI/ACE and a prior notice confirmation number has been received before the system outages, the submitter may proceed with prior notice using the standard process. However, if prior notice was submitted via ABI/ACE but a prior notice confirmation number has not been received before the outages, submitters should provide a signed copy of the ABI transmission or other evidence to show that prior notice has been submitted via ABI/ACE, to CBP officers at the time of cargo release.

If prior notice was submitted via PNSI and a confirmation number has been received before the system outage, the confirmation number must accompany the article of food and must be provided to CBP or FDA upon arrival (21 CFR 1.279(g)). In addition, FDA and CBP recommend that the PNSI confirmation page, including the prior notice confirmation number and time stamp, be provided to CBP officers for cargo release. If the PNSI confirmation page is not provided, it may delay cargo release.

If prior notice was not submitted before the outages, prior notice may be submitted by either email or fax. FDA will not accept any prior notice submitted by these methods other than during PNSI downtimes.

1. E-mail Submission

FDA will post a link (URL) to the contingency submission form (FDA 3540) at https://www.access.fda.gov (see log-in page) and will request that CBP post a message on the CSMS website. When this option is activated, the FDA’s Division of Food Defense Targeting (DFDT) intends to send an automated receipt response, including the prior notice confirmation number, to the e-mail address from which the prior notice was transmitted. A paper copy of the e-mail receipt confirmation should be presented to the CBP officer for cargo release. CBP intends to enforce prior notice submission time frames based on the email receipt confirmation time stamp.

2. Fax submission

FDA will publish the fax number to the DFDT at https://www.access.fda.gov (see log-in page) and will request that CBP post a message on the CSMS website. When this option is activated, DFDT intends to return a fax acknowledgement report including the prior notice confirmation number. The fax acknowledgement report should be presented to the CBP officer for cargo release. CBP intends to enforce prior notice submission time frames based on the fax acknowledgement report confirmation time stamp.

FDA intends to post a notice once normal processing has resumed at https://www.access.fda.gov (see log-in page) and will request that CBP post a similar message on the CSMS website.

If possible, FDA will post a notice that includes a link to the prior notice contingency submission form (FDA 3540) at https://www.access.fda.gov (see log-in page) and will request that CBP issue an administrative message to brokers through CBP’s Cargo Systems Messaging Service (CSMS) website.

If prior notice has not been submitted prior to the outage, filers may decide to wait out the downtime if the timeliness of prior notice will not be affected. Filers who choose this option remain responsible for filing timely prior notice under section 801(m) of the Act and under the prior notice final rule.

For the duration of this contingency scenario, filers should submit the required prior notice information to FDA at the port of arrival or if there is no FDA officer at a given port, to CBP via a paper copy of the contingency submission form at the time of cargo release.

FDA intends to post a notice once normal processing has resumed at https://www.access.fda.gov (see log-in page) and will request that CBP post a similar message on the CSMS website.

Visit https://www.access.fda.gov/ to consult PNSI.