Prior Notice of Imported Food 
Contingency Plan for System Outages: 
Guidance for Industry 
 
 
 
 
Submit one set of either electronic or written comments on this guidance at any time.  Submit 
electronic comments to https://www.regulations.gov/.  Submit written comments to the Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.  You should identify all comments with docket number FDA-2004-D-
0042. 
For questions regarding this document contact Food and Drug Administration, Office of 
Regulatory Affairs, Office of Enforcement and Import Operations, Division of Food Defense 
Targeting, Element Bldg., HFC-180, 12420 Parklawn Dr., Rockville, MD 20857-20993, e-mail: 
prior.notice@fda.hhs.gov, phone number: 866-521-2297. 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Regulatory Affairs 
November 2020 
 
 
   
 
  Contains Nonbinding Recommendations 
Table of Contents 
I.  INTRODUCTION 
II.  BACKGROUND 
III.  PRIOR NOTICE CONTINGENCY PLAN 
1.  Scenario 1 -- ACE, OASIS, and PNSI are working, but the link between ACE and 
OASIS is down. 
 
2.  Scenario 2 -- ACE, PNSI, and the link between ACE and OASIS are working, but 
OASIS is down. 
 
3.  Scenario 3 -- ACE and the link between ACE and OASIS are working, but OASIS 
and PNSI are down.   
 
4.  Scenario 4 -- ACE, OASIS, and the link between ACE and OASIS are working, 
but PNSI is down. 
 
5.  Scenario 5 -- OASIS, PNSI, and the link between ACE and OASIS are working, 
but ACE is down. 
 
6.  Scenario 6 -- ACE and PNSI are down. 
 
7.  Scenario 7 -- Localized or regional power failure or other emergencies. 
   
2  Contains Nonbinding Recommendations 
Prior Notice of Imported Food Contingency Plan for 
System Outages: Guidance for Industry1 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) and U.S. Customs and Border Protection (CBP) on this topic. It does not establish any 
rights for any person and is not binding on FDA, CBP, or the public. You can use an alternative 
approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an 
alternative approach, contact the FDA staff responsible for this guidance as listed on the title 
page. 
 
I. INTRODUCTION 
 
This guidance document provides recommendations for submitting prior notice of imported food 
during system outages affecting the applicable FDA and U.S. Customs and Border Protection 
(CBP) program systems. 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the FDAs current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited. 
The use of the word should in FDA guidances means that something is suggested or 
recommended, but not required. 
II. BACKGROUND 
Section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 
2002 added section 801(m) to the Federal Food, Drug, and Cosmetic Act (the Act) to require that 
FDA receive prior notice for food imported or offered for import into the United States. An 
article of food imported or offered for import without prior notice in accordance with the Act 
shall be refused admission into the United States under section 801(m)(1) of the Act. 
Prior notice regulations (21 CFR 1.276-1.285) set out the requirements for submitting prior 
notice of imported food. All submissions must be made electronically and must be submitted 
through the CBP Automated Broker Interface/Automated Commercial 
Environment/International Trade Data System (ABI/ACE/ITDS) or the FDA Prior Notice 
System Interface (PNSI) at https://www.access.fda.gov (21 CFR 1.280). If FDA determines that 
FDA PNSI or the Operational and Administration System for Import Support (OASIS) is not 
working, FDA will post prominent notification and instructions at https://www.access.fda.gov 
(see log-in page) (21 CFR 1.280(c)). 
FDA and CBP have identified seven system downtime scenarios that could impact transmission, 
confirmation, and processing of prior notice submissions and have developed alternative 
submission options for each of the identified scenarios. In these situations, FDA will accept prior 
                                                           
1 This guidance has been prepared by the Office of Regulatory Affairs at the U.S. Food and Drug Administration in 
cooperation with the U.S. Customs and Border Protection at the Department of Homeland Security. 
3  Contains Nonbinding Recommendations 
notice submissions in the format it deems appropriate at the time (21 CFR 1.280(c)), such as by 
e-mail or fax (telephonic facsimile). When the alternate submission options include both e-mail 
and fax transmissions, e-mail transmission is encouraged as the more efficient means. 
Any reference to ACE as not working only refers to the CBP ACE itself. If a filer/transmitters 
ABI system is not working, arrangements should be made to transmit prior notice via another 
filer or via PNSI (21 CFR 1.280(b)). 
III. 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. 
2. Scenario 2: ACE, PNSI, and the link between ACE and OASIS are working, but 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. 
4  Contains Nonbinding Recommendations 
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. 
3. Scenario 3: ACE and the link between ACE and OASIS are working, but OASIS and 
PNSI are down. 
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 
5  Contains Nonbinding Recommendations 
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 FDAs 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 e-
mail 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. 
4. Scenario 4: ACE, OASIS, and the link between ACE and OASIS are working, but PNSI 
is down. 
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. 
6  Contains Nonbinding Recommendations 
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 FDAs 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 e-
mail 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. 
5. Scenario 5: OASIS, PNSI and the link between ACE and OASIS are working, but ACE 
is down. 
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. 
7  Contains Nonbinding Recommendations 
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. 
6. Scenario 6: ACE and PNSI are down.  
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.  
8  Contains Nonbinding Recommendations 
If prior notice was not submitted before the outages, prior notice may be submitted by either e-
mail 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 FDAs 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 e-
mail 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. 
7. Scenario 7: Localized or regional power failure or other emergencies. 
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 CBPs 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. 
9